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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04227899




Registration number
NCT04227899
Ethics application status
Date submitted
6/01/2020
Date registered
14/01/2020
Date last updated
4/05/2021

Titles & IDs
Public title
LIFE-BTK Randomized Controlled Trial
Scientific title
LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial
Secondary ID [1] 0 0
ABT-CIP-10293
Universal Trial Number (UTN)
Trial acronym
LIFE-BTK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Limb Ischemia (CLI) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Esprit BTK Device
Treatment: Devices - Percutaneous Transluminal Angioplasty (PTA) Device

Experimental: Esprit BTK - Participants who receives Esprit BTK device will be included in this arm

Active Comparator: Percutaneous Transluminal Angioplasty (PTA) - Participants who receives PTA treatment will be included in this arm


Treatment: Devices: Esprit BTK Device
Participants will receive Esprit BTK Device

Treatment: Devices: Percutaneous Transluminal Angioplasty (PTA) Device
Participants will receive PTA treatment

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Limb Salvage and Primary Patency at 6 Months - It includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [1] 0 0
At 6 months
Primary outcome [2] 0 0
Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes above ankle amputation in index limb, major re-intervention at 6 months and POD includes perioperative (30 day) mortality.
Timepoint [2] 0 0
At 30 days (for POD) and 6 months (for MALE)
Secondary outcome [1] 0 0
Number of Participants with Acute Procedure Success - Successful target lesion treatment is defined as final diameter stenosis < 30% with final number of run-off vessels equivalent to or greater than number of run-off vessels at pre-procedure, with no residual dissection NHLBI grade = type C, and no transient or sustained angiographic complications (e.g. distal embolization, perforation, thrombosis). Achieved using balloons plus Esprit BTK in the treatment arm and balloons in the control arm. This is defined on a per lesion basis.
Timepoint [1] 0 0
Immediately after the procedure
Secondary outcome [2] 0 0
Number of Participants with Device Success - Device success is defined on a per device basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.
Timepoint [2] 0 0
During the procedure
Secondary outcome [3] 0 0
Number of Participants with Technical Success - Technical success is defined on a per lesion basis as the attainment of a final residual stenosis of < 30% at the intended target lesion(s) following use of the study device(s). Standard pre-dilatation catheters and post-dilatation catheters (if applicable) may be used. Bailout at lesion level does not impact technical success if the above criteria are met.
Timepoint [3] 0 0
Immediately after the procedure
Secondary outcome [4] 0 0
Number of Participants with Clinical Success - Clinical success is defined on a per patient basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.
Timepoint [4] 0 0
Within 2 days after the index procedure or at hospital discharge
Secondary outcome [5] 0 0
Number of Participants with Angiographic acute gain (in-segment) - Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD).
Timepoint [5] 0 0
Immediately after the procedure
Secondary outcome [6] 0 0
Number of Participants with Angiographic acute gain (in-device) - Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD). Angiographic acute gain (in-device) will be assessed for Esprit arm only
Timepoint [6] 0 0
Immediately after the procedure
Secondary outcome [7] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [7] 0 0
At 1 month
Secondary outcome [8] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [8] 0 0
At 3 months
Secondary outcome [9] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [9] 0 0
At 6 months
Secondary outcome [10] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [10] 0 0
At 1 year
Secondary outcome [11] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [11] 0 0
At 2 years
Secondary outcome [12] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [12] 0 0
At 3 years
Secondary outcome [13] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [13] 0 0
At 4 years
Secondary outcome [14] 0 0
Composite of Limb Salvage and Primary Patency - Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Timepoint [14] 0 0
At 5 years
Secondary outcome [15] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 1 month and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [15] 0 0
At 30 days (for POD) and 1 month (for MALE)
Secondary outcome [16] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 3 months and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [16] 0 0
At 30 days (for POD) and 3 months (for MALE)
Secondary outcome [17] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 6 months and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [17] 0 0
At 30 days (for POD) and 6 months (for MALE)
Secondary outcome [18] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 1 year and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [18] 0 0
At 30 days (for POD) and 1 year (for MALE)
Secondary outcome [19] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 2 years and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [19] 0 0
At 30 days (for POD) and 2 years (for MALE)
Secondary outcome [20] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 3 years and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [20] 0 0
At 30 days (for POD) and 3 years (for MALE)
Secondary outcome [21] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 4 years and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [21] 0 0
At 30 days (for POD) and 4 years (for MALE)
Secondary outcome [22] 0 0
Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) - MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 5 years and POD includes peri-procedural (or peri-operative) death at 30-days.
Timepoint [22] 0 0
At 30 days (for POD) and 5 years (for MALE)
Secondary outcome [23] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [23] 0 0
At 1 month
Secondary outcome [24] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [24] 0 0
At 3 months
Secondary outcome [25] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [25] 0 0
At 6 months
Secondary outcome [26] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [26] 0 0
At 1 year
Secondary outcome [27] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [27] 0 0
At 2 years
Secondary outcome [28] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [28] 0 0
At 3 years
Secondary outcome [29] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [29] 0 0
At 4 years
Secondary outcome [30] 0 0
Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) - Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [30] 0 0
At 5 years
Secondary outcome [31] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [31] 0 0
At 1 month
Secondary outcome [32] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [32] 0 0
At 3 months
Secondary outcome [33] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [33] 0 0
At 6 months
Secondary outcome [34] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [34] 0 0
At 1 year
Secondary outcome [35] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [35] 0 0
At 2 years
Secondary outcome [36] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [36] 0 0
At 3 years
Secondary outcome [37] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [37] 0 0
At 4 years
Secondary outcome [38] 0 0
Freedom From Above Ankle Amputation - Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
Timepoint [38] 0 0
At 5 years
Secondary outcome [39] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [39] 0 0
At 1 month
Secondary outcome [40] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [40] 0 0
At 3 months
Secondary outcome [41] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [41] 0 0
At 6 months
Secondary outcome [42] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [42] 0 0
At 1 year
Secondary outcome [43] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [43] 0 0
At 2 years
Secondary outcome [44] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [44] 0 0
At 3 years
Secondary outcome [45] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [45] 0 0
At 4 years
Secondary outcome [46] 0 0
Freedom From Restenosis - Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (= 50%), which is determined by angiography.
Timepoint [46] 0 0
At 5 years
Secondary outcome [47] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [47] 0 0
At 1 month
Secondary outcome [48] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [48] 0 0
At 3 months
Secondary outcome [49] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [49] 0 0
At 6 months
Secondary outcome [50] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [50] 0 0
At 1 year
Secondary outcome [51] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [51] 0 0
At 2 year
Secondary outcome [52] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [52] 0 0
At 3 years
Secondary outcome [53] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [53] 0 0
At 4 years
Secondary outcome [54] 0 0
Number of Amputation-free Survival - Amputation-free survival includes freedom from above ankle amputation and death.
Timepoint [54] 0 0
At 5 years
Secondary outcome [55] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [55] 0 0
At 1 month
Secondary outcome [56] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [56] 0 0
At 3 months
Secondary outcome [57] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [57] 0 0
At 6 months
Secondary outcome [58] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [58] 0 0
At 1 year
Secondary outcome [59] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [59] 0 0
At 2 years
Secondary outcome [60] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [60] 0 0
At 3 years
Secondary outcome [61] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [61] 0 0
At 4 years
Secondary outcome [62] 0 0
Number of All-cause Death - All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Timepoint [62] 0 0
At 5 years
Secondary outcome [63] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [63] 0 0
At 1 month
Secondary outcome [64] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [64] 0 0
At 3 months
Secondary outcome [65] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [65] 0 0
At 6 months
Secondary outcome [66] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [66] 0 0
At 1 year
Secondary outcome [67] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [67] 0 0
At 2 years
Secondary outcome [68] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [68] 0 0
At 3 years
Secondary outcome [69] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [69] 0 0
At 4 years
Secondary outcome [70] 0 0
Number of Participants with Arterial Thrombosis - Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
Acute thrombosis: 0 - 24 hours post study procedure
Subacute thrombosis: > 24 hours - 30 days post study procedure
Late thrombosis: 31 days - 1 year post-procedure
Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Timepoint [70] 0 0
At 5 years
Secondary outcome [71] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [71] 0 0
At 1 month
Secondary outcome [72] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [72] 0 0
At 3 months
Secondary outcome [73] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [73] 0 0
At 6 months
Secondary outcome [74] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [74] 0 0
At 1 year
Secondary outcome [75] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [75] 0 0
At 2 years
Secondary outcome [76] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [76] 0 0
At 3 years
Secondary outcome [77] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [77] 0 0
At 4 years
Secondary outcome [78] 0 0
Number of Participants with Major Re-intervention on index limb - Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Timepoint [78] 0 0
At 5 years
Secondary outcome [79] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [79] 0 0
At 1 month
Secondary outcome [80] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [80] 0 0
At 3 months
Secondary outcome [81] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [81] 0 0
At 6 months
Secondary outcome [82] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [82] 0 0
At 1 year
Secondary outcome [83] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [83] 0 0
At 2 years
Secondary outcome [84] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [84] 0 0
At 3 years
Secondary outcome [85] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [85] 0 0
At 4 years
Secondary outcome [86] 0 0
Primary Assisted Patency - Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Timepoint [86] 0 0
At 5 years
Secondary outcome [87] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [87] 0 0
At 1 month
Secondary outcome [88] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [88] 0 0
At 3 months
Secondary outcome [89] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [89] 0 0
At 6 months
Secondary outcome [90] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [90] 0 0
At 1 year
Secondary outcome [91] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [91] 0 0
At 2 years
Secondary outcome [92] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [92] 0 0
At 3 years
Secondary outcome [93] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [93] 0 0
At 4 years
Secondary outcome [94] 0 0
Secondary Patency - Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Timepoint [94] 0 0
At 5 years
Secondary outcome [95] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [95] 0 0
At 1 month
Secondary outcome [96] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [96] 0 0
At 3 months
Secondary outcome [97] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [97] 0 0
At 6 months
Secondary outcome [98] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [98] 0 0
At 1 year
Secondary outcome [99] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [99] 0 0
At 2 years
Secondary outcome [100] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [100] 0 0
At 3 years
Secondary outcome [101] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [101] 0 0
At 4 years
Secondary outcome [102] 0 0
Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) - CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR
Timepoint [102] 0 0
At 5 years
Secondary outcome [103] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [103] 0 0
At 1 month
Secondary outcome [104] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [104] 0 0
At 3 months
Secondary outcome [105] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [105] 0 0
At 6 months
Secondary outcome [106] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [106] 0 0
At 1 year
Secondary outcome [107] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [107] 0 0
At 2 years
Secondary outcome [108] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [108] 0 0
At 3 years
Secondary outcome [109] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [109] 0 0
At 4 years
Secondary outcome [110] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) - CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography
Timepoint [110] 0 0
At 5 years
Secondary outcome [111] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [111] 0 0
At 1 month
Secondary outcome [112] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [112] 0 0
At 3 months
Secondary outcome [113] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [113] 0 0
At 6 months
Secondary outcome [114] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [114] 0 0
At 1 year
Secondary outcome [115] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [115] 0 0
At 2 years
Secondary outcome [116] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [116] 0 0
At 3 years
Secondary outcome [117] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [117] 0 0
At 4 years
Secondary outcome [118] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion - Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
Timepoint [118] 0 0
At 5 years
Secondary outcome [119] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [119] 0 0
At 1 month
Secondary outcome [120] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [120] 0 0
At 3 months
Secondary outcome [121] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [121] 0 0
At 6 months
Secondary outcome [122] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [122] 0 0
At 1 year
Secondary outcome [123] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [123] 0 0
At 2 years
Secondary outcome [124] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [124] 0 0
At 3 years
Secondary outcome [125] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [125] 0 0
At 4 years
Secondary outcome [126] 0 0
Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion - Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
Timepoint [126] 0 0
At 5 years
Secondary outcome [127] 0 0
Index Wound Assessment for Healing at 14 days - Index wound assessment for healing will be assessed by the core laboratory at 14 days
Timepoint [127] 0 0
At 14 days
Secondary outcome [128] 0 0
Index Wound Assessment for Healing at 30 days - Index wound assessment for healing will be assessed by the core laboratory at 30 days
Timepoint [128] 0 0
At 30 days
Secondary outcome [129] 0 0
Index Wound Assessment for Healing at 42 days - Index wound assessment for healing will be assessed by the core laboratory at 42 days
Timepoint [129] 0 0
At 42 days
Secondary outcome [130] 0 0
Index Wound Assessment for Healing at 90 days - Index wound assessment for healing will be assessed by the core laboratory at 90 days
Timepoint [130] 0 0
At 90 days
Secondary outcome [131] 0 0
Index Wound Assessment for Healing at 180 days - Index wound assessment for healing will be assessed by the core laboratory at 180 days
Timepoint [131] 0 0
At 180 days
Secondary outcome [132] 0 0
Index Wound Assessment for Healing at 1 year - Index wound assessment for healing will be assessed by the core laboratory at 1 year
Timepoint [132] 0 0
At 1 year
Secondary outcome [133] 0 0
Index Wound Assessment for Infection at 14 days - Index wound assessment for infection will be assessed by the core laboratory at 14 days.
Timepoint [133] 0 0
At 14 days
Secondary outcome [134] 0 0
Index Wound Assessment for Infection at 30 days - Index wound assessment for infection will be assessed by the core laboratory at 30 days.
Timepoint [134] 0 0
At 30 days
Secondary outcome [135] 0 0
Index Wound Assessment for Infection at 42 days - Index wound assessment for infection will be assessed by the core laboratory at 42 days.
Timepoint [135] 0 0
At 42 days
Secondary outcome [136] 0 0
Index Wound Assessment for Infection at 90 days - Index wound assessment for infection will be assessed by the core laboratory at 90 days.
Timepoint [136] 0 0
At 90 days
Secondary outcome [137] 0 0
Index Wound Assessment for Infection at 180 days - Index wound assessment for infection will be assessed by the core laboratory at 180 days.
Timepoint [137] 0 0
At 180 days
Secondary outcome [138] 0 0
Index Wound Assessment for Infection at 1 year - Index wound assessment for infection will be assessed by the core laboratory at 1 year.
Timepoint [138] 0 0
At 1 year
Secondary outcome [139] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [139] 0 0
At baseline
Secondary outcome [140] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [140] 0 0
At 1 month
Secondary outcome [141] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [141] 0 0
At 3 months
Secondary outcome [142] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [142] 0 0
At 6 months
Secondary outcome [143] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [143] 0 0
At 1 year
Secondary outcome [144] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [144] 0 0
At 2 years
Secondary outcome [145] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [145] 0 0
At 3 years
Secondary outcome [146] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [146] 0 0
At 4 years
Secondary outcome [147] 0 0
Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb - The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Timepoint [147] 0 0
At 5 years
Secondary outcome [148] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [148] 0 0
At 1 month
Secondary outcome [149] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [149] 0 0
At 3 months
Secondary outcome [150] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [150] 0 0
At 6 months
Secondary outcome [151] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [151] 0 0
At 1 year
Secondary outcome [152] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [152] 0 0
At 2 years
Secondary outcome [153] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [153] 0 0
At 3 years
Secondary outcome [154] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [154] 0 0
At 4 years
Secondary outcome [155] 0 0
Occurrence of new wound - New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
Timepoint [155] 0 0
At 5 years
Secondary outcome [156] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [156] 0 0
At 1 month
Secondary outcome [157] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [157] 0 0
At 3 months
Secondary outcome [158] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [158] 0 0
At 6 months
Secondary outcome [159] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [159] 0 0
At 1 year
Secondary outcome [160] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [160] 0 0
At 2 years
Secondary outcome [161] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [161] 0 0
At 3 years
Secondary outcome [162] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [162] 0 0
At 4 years
Secondary outcome [163] 0 0
Number of patients with acute limb ischemia - Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
Timepoint [163] 0 0
At 5 years
Secondary outcome [164] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [164] 0 0
At 1 month
Secondary outcome [165] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [165] 0 0
At 3 months
Secondary outcome [166] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [166] 0 0
At 6 months
Secondary outcome [167] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [167] 0 0
At 1 year
Secondary outcome [168] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [168] 0 0
At 2 years
Secondary outcome [169] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [169] 0 0
At 3 years
Secondary outcome [170] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [170] 0 0
At 4 years
Secondary outcome [171] 0 0
Number of patients with peripheral embolization - Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
Timepoint [171] 0 0
At 5 years

Eligibility
Key inclusion criteria
General

1. Subject must provide written informed consent prior to any clinical investigation
related procedure.

2. Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical
Category 4 or 5.

3. Subject requires primary treatment of up to two de novo or restenotic (treated with
prior PTA) infrapopliteal lesions

4. Subject must be at least 18 years of age.

5. Female subject of childbearing potential should not be pregnant and must be on birth
control.

Note: Female subjects of child-bearing potential must have a negative pregnancy test done
within 7 days prior to the index procedure per site standard test.

Anatomic

1. Up to two native infrapopliteal lesions, each lesion located in separate
infrapopliteal vessel in the same limb. Restenotic (from prior PTA) lesions are
allowed.

1. Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with
vessel diameter of = 2.5 mm and = 4.00 mm by investigator visual assessment.

2. Total scaffold length to completely cover/treat a target lesion must not exceed
170 mm (total everolimus drug dose of 1790 µg).

3. The total scaffold length among all target lesions must not exceed 170 mm.

4. The target vessel cannot have any other angiographic significant lesions (=50%).

5. Tandem lesions are allowed if they are < 3 cm apart and the total scaffold length
used to cover the entire diseased segment is = 170 mm. Each tandem lesion is
considered one lesion.

2. Target lesion(s) must have = 70% stenosis, per visual assessment at the time of the
procedure. If needed, quantitative imaging (angiography, IVUS, and/or OCT) can be used
to aid accurate sizing of the vessels.

3. The distal margin of the target lesion must be located = 10 cm proximal to the
proximal margin of the ankle mortise. The vessel segment distal to the target lesion
must be patent all the way to the ankle, with no significant lesion (= 50% stenosis).

4. Significant lesion (= 50% stenosis) in the inflow artery(ies) must be treated
successfully (as per physician's assessment of the angiography) through standard of
care prior to the treatment of the target lesion. Treatment can be done within the
same trial procedure

5. Non-target lesion(s) (if applicable) must be located in separate infrapopliteal
vessel(s) from the target lesion, and suitable to be treated per institution standard
of care.

6. Guidewire must cross the target lesion successfully. Crossing in an antegrade fashion
is preferred, but retrograde crossing may be used. However, the treatment must be
delivered antegrade.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General

1. Subject is currently participating in another clinical investigation that has not yet
completed its primary endpoint.

2. Pregnant or nursing subjects and those who plan pregnancy during the clinical
investigation follow-up period.

3. Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements.

4. Incapacitated individuals, defined as persons who are mentally ill, mentally
handicapped, or individuals without legal authority, are excluded from the study
population.

5. Subject has had any amputation to the ipsilateral, or contralateral extremity other
than the toe or forefoot.

6. Subject has known hypersensitivity or contraindication to device material and its
degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and
cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot
be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be
adequately pre-medicated.

7. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin;
or to ADP antagonists such clopidogrel, prasugrel or ticagrelor; or to anticoagulants
such as heparin or bivalirudin, and therefore cannot be adequately treated with study
medications. Subject with planned surgery or procedure necessitating discontinuation
of antiplatelet medications, within 12 months after index procedure.

8. Subject has life expectancy = 1 year.

9. Subject has had a stroke within the previous 3 months with residual Rankin score of =
2.

10. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min per
1.73m^2.

11. Subject is currently on dialysis.

12. Subject has platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3, a WBC < 3,000
cells/mm^3, or hemoglobin < 9.0 g/dl.

13. Subject has known serious immunosuppressive disease (e.g., human immunodeficiency
virus), or has severe autoimmune disease, that requires chronic immunosuppressive
therapy (e.g., systemic lupus erythematosus, etc.), or subject is receiving
immunosuppression therapy for other conditions.

14. Subject has Body Mass Index (BMI) <18.

15. Subject is receiving or scheduled to receive anticancer therapy for malignancy within
1 year prior to or after the procedure.

16. Subject has coagulation disorder.

17. Subject who requires thrombolysis as a primary treatment modality or requires other
treatment for acute limb ischemia of the target limb.

18. Subject has previously had, or requires surgical revascularization involving any
vessel of the ipsilateral extremity. Prior femoropopliteal or aortobifemoral bypass is
allowed. Any bypass to the tibial arteries is not allowed.

19. Subject has signs or symptoms of advanced limb infection or septicemia (fever > 38.5,
WBC > 15,000 cells/microliter, hypotension) at the time of assessment. Osteomyelitis
of the phalanges or metatarsal heads (as described in exclusion criteria #21a) or
cellulitis of the foot amenable to treatment with IV antibiotics at the time of
revascularization is acceptable.

20. Subject is bedridden or unable to walk (with assistance is acceptable).

21. Subject with extensive tissue loss salvageable only with complex foot reconstruction
or non-traditional transmetatarsal amputations. This includes subjects with:

1. Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis
limited to the phalanges or metatarsal heads is acceptable for enrollment.

2. Gangrene involving the plantar skin of the forefoot, midfoot, or heel

3. Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the
forefoot, midfoot, or heel

4. Full thickness heel ulcer with/without calcaneal involvement

5. Any wound with calcaneal bone involvement

6. Wounds that are deemed to be neuropathic or non-ischemic in nature

7. Wounds that would require flap coverage or complex wound management for large
soft tissue defect

8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone.

22. Subject is unable or unwilling to provide written consent prior to enrollment

23. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly
spreading novel infectious agent within the prior 2 months

Anatomic

1. Lesions with severe calcification, in which there is a high likelihood that successful
pre-dilatation cannot be achieved.

2. Lesion that has prior metallic stent implant.

3. Significant (-= 50% stenosis) lesion in a distal outflow artery that would be perfused
by the target vessel and that requires treatment at the time of the index procedure.

4. Inflow lesions or non-target infrapopliteal lesions that were treated using paclitaxel
coated or eluting stents or DCB, during the index procedure.

5. Subject has had or will require treatment in any peripheral anatomy vessel with a
drug-coated or drug-eluting device < 90 days pre-study procedure.

6. Target or (if applicable) non-target vessel contains visible thrombus as indicated in
the angiographic images.

7. Subject has angiographic evidence of thromboembolism or atheroembolism in the
ipsilateral extremity. (Pre- and post-angiographic imaging must confirm the absence of
emboli in the distal anatomy.)

8. Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting
arterial lesions left untreated.

9. No angiographic evidence of a patent pedal artery.

10. Target or (if applicable) non-target lesion location requiring bifurcation treatment
method that requires scaffolding of both branches (provisional treatment, without
intention of scaffolding both branches is acceptable).

11. Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery
of the ipsilateral extremity.

12. Visual assessment of the target lesion suggests that the investigator is unable to
pre-dilate the lesion according to the vessel diameter.

13. Target lesion has a high probability that atherectomy will be required at the time of
index procedure for treatment of the target vessel.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
Singapore
State/province [26] 0 0
Singapore
Country [27] 0 0
Taiwan
State/province [27] 0 0
Xindian
Country [28] 0 0
Taiwan
State/province [28] 0 0
Zhongzheng

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Pre-market clinical evaluation of the everolimus eluting Espritâ„¢ BTK System for the planned
treatment of narrowed infrapopliteal lesions.
Trial website
https://clinicaltrials.gov/show/NCT04227899
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ramon L Varcoe, MBBS, MS, FRACS, PhD
Address 0 0
Prince of Wales Private Hospital, Randwick, NSW, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rhonda Hensley
Address 0 0
Country 0 0
Phone 0 0
+1 (828) 527-9054
Fax 0 0
Email 0 0
rhonda.hensley@abbott.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04227899