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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02173379




Registration number
NCT02173379
Ethics application status
Date submitted
9/06/2014
Date registered
25/06/2014
Date last updated
6/11/2019

Titles & IDs
Public title
Absorb IV Randomized Controlled Trial
Scientific title
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Secondary ID [1] 0 0
10-392 C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Coronary Artery Stenosis 0 0
Coronary Disease 0 0
Coronary Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Absorb BVS
Treatment: Devices - XIENCE

Experimental: Absorb BVS - Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System

Active Comparator: XIENCE - Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only)


Treatment: Devices: Absorb BVS
Scaffold diameters: 2.5, 3.0 and 3.5 mm
Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.
The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length = 24 mm) with a reference vessel diameter of = 2.5 mm and = 3.75 mm.

Treatment: Devices: XIENCE
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition
Stent lengths: 8, 12, 15, 18, 23, and 28 mm
For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length = 24 mm) with a reference vessel diameter of = 2.5 mm and = 3.75 mm.

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Target Lesion Failure (TLF) - Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Powered TLF, Tested for Non-inferiority of Absorb BVS to XIENCE - This analysis will consist of ~2610 subjects in ABSORB IV.
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Number of Participants With Powered Angina - Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) - Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Timepoint [3] 0 0
In-hospital (= 7days)
Secondary outcome [4] 0 0
Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) - Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Timepoint [4] 0 0
In-hospital (= 7days)
Secondary outcome [5] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [5] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [6] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [7] 0 0
90 days
Secondary outcome [8] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [8] 0 0
180 days
Secondary outcome [9] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [9] 0 0
270 days
Secondary outcome [10] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [12] 0 0
3 years
Secondary outcome [13] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [13] 0 0
4 years
Secondary outcome [14] 0 0
Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Timepoint [14] 0 0
5 years
Secondary outcome [15] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [15] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [16] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [16] 0 0
30 days
Secondary outcome [17] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [17] 0 0
90 days
Secondary outcome [18] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [18] 0 0
180 days
Secondary outcome [19] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [19] 0 0
270 days
Secondary outcome [20] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [20] 0 0
1 year
Secondary outcome [21] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [21] 0 0
2 years
Secondary outcome [22] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [22] 0 0
3 years
Secondary outcome [23] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [23] 0 0
4 years
Secondary outcome [24] 0 0
Number of Participants With Myocardial Infarction (MI) - Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Timepoint [24] 0 0
5 years
Secondary outcome [25] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [25] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [26] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [26] 0 0
30 days
Secondary outcome [27] 0 0
Number of Participants withTarget Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [27] 0 0
90 days
Secondary outcome [28] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [28] 0 0
180 days
Secondary outcome [29] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [29] 0 0
270 days
Secondary outcome [30] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [30] 0 0
1 year
Secondary outcome [31] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [31] 0 0
2 years
Secondary outcome [32] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [32] 0 0
3 years
Secondary outcome [33] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [33] 0 0
4 years
Secondary outcome [34] 0 0
Number of Participants With Target Lesion Revascularization (TLR) - TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Timepoint [34] 0 0
5 years
Secondary outcome [35] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [35] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [36] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [36] 0 0
30 days
Secondary outcome [37] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [37] 0 0
90 days
Secondary outcome [38] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR.
-TVR includes all TVR, excluding TLR
Timepoint [38] 0 0
180 days
Secondary outcome [39] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [39] 0 0
270 days
Secondary outcome [40] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [40] 0 0
1 year
Secondary outcome [41] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [41] 0 0
2 years
Secondary outcome [42] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [42] 0 0
3 years
Secondary outcome [43] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [43] 0 0
4 years
Secondary outcome [44] 0 0
Number of Participants With Target Vessel Revascularization (TVR) - TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Timepoint [44] 0 0
5 years
Secondary outcome [45] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [45] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [46] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [46] 0 0
30 days
Secondary outcome [47] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [47] 0 0
90 days
Secondary outcome [48] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [48] 0 0
180 days
Secondary outcome [49] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [49] 0 0
270 days
Secondary outcome [50] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [50] 0 0
1 year
Secondary outcome [51] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [51] 0 0
2 years
Secondary outcome [52] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [52] 0 0
3 years
Secondary outcome [53] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [53] 0 0
4 years
Secondary outcome [54] 0 0
Number of Participants With All Coronary Revascularization - Revascularization includes TLR, TVR excluding TLR, and non TVR.
Timepoint [54] 0 0
5 years
Secondary outcome [55] 0 0
Number of Participants Experienced All Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [55] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [56] 0 0
Number of Participants Experienced All Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [56] 0 0
30 days
Secondary outcome [57] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [57] 0 0
90 days
Secondary outcome [58] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [58] 0 0
180 days
Secondary outcome [59] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [59] 0 0
270 days
Secondary outcome [60] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [60] 0 0
1 year
Secondary outcome [61] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [61] 0 0
2 years
Secondary outcome [62] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [62] 0 0
3 years
Secondary outcome [63] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [63] 0 0
4 years
Secondary outcome [64] 0 0
Number of Participants Experienced Death/All MI - All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Timepoint [64] 0 0
5 years
Secondary outcome [65] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [65] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [66] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [66] 0 0
30 days
Secondary outcome [67] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [67] 0 0
90 days
Secondary outcome [68] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [68] 0 0
180 days
Secondary outcome [69] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [69] 0 0
270 days
Secondary outcome [70] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [70] 0 0
1 year
Secondary outcome [71] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [71] 0 0
2 years
Secondary outcome [72] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [72] 0 0
3 years
Secondary outcome [73] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [73] 0 0
4 years
Secondary outcome [74] 0 0
Number of Participants Experienced Cardiac Death/All MI - Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Timepoint [74] 0 0
5 years
Secondary outcome [75] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [75] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [76] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [76] 0 0
90 days
Secondary outcome [77] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [77] 0 0
180 days
Secondary outcome [78] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [78] 0 0
270 days
Secondary outcome [79] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [79] 0 0
1 year
Secondary outcome [80] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [80] 0 0
2 years
Secondary outcome [81] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [81] 0 0
3 years
Secondary outcome [82] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [82] 0 0
4 years
Secondary outcome [83] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) - Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Timepoint [83] 0 0
5 years
Secondary outcome [84] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [84] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [85] 0 0
Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [85] 0 0
30 days
Secondary outcome [86] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [86] 0 0
90 days
Secondary outcome [87] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [87] 0 0
180 days
Secondary outcome [88] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [88] 0 0
270 days
Secondary outcome [89] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [89] 0 0
1 year
Secondary outcome [90] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [90] 0 0
2 years
Secondary outcome [91] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [91] 0 0
3 years
Secondary outcome [92] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [92] 0 0
4 years
Secondary outcome [93] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) - Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Timepoint [93] 0 0
5 years
Secondary outcome [94] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [94] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [95] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [95] 0 0
30 days
Secondary outcome [96] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [96] 0 0
90 days
Secondary outcome [97] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [97] 0 0
180 days
Secondary outcome [98] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [98] 0 0
270 days
Secondary outcome [99] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [99] 0 0
1 year
Secondary outcome [100] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [100] 0 0
2 years
Secondary outcome [101] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [101] 0 0
3 years
Secondary outcome [102] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [102] 0 0
4 years
Secondary outcome [103] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) - Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Timepoint [103] 0 0
5 years
Secondary outcome [104] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR) - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [104] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [105] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [105] 0 0
30 days
Secondary outcome [106] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [106] 0 0
90 days
Secondary outcome [107] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [107] 0 0
180 days
Secondary outcome [108] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [108] 0 0
270 days
Secondary outcome [109] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [109] 0 0
1 year
Secondary outcome [110] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [110] 0 0
2 years
Secondary outcome [111] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [111] 0 0
3 years
Secondary outcome [112] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [112] 0 0
4 years
Secondary outcome [113] 0 0
Number of Participants Experienced Death/All MI/All Revascularization - DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Timepoint [113] 0 0
5 years
Secondary outcome [114] 0 0
Number of Participants With Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) - Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Timepoint [114] 0 0
Acute (0 - 24 hours post stent implantation)
Secondary outcome [115] 0 0
Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition) - Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Timepoint [115] 0 0
Subacute (>24 hours - 30 days post stent implantation)
Secondary outcome [116] 0 0
Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition) - Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Timepoint [116] 0 0
Late (30 days - 1 year post stent implantation)
Secondary outcome [117] 0 0
Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition) - Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained
Timepoint [117] 0 0
Very late (>1 year post stent implantation)
Secondary outcome [118] 0 0
Number of Participants With Rehospitalization - Coronary artery disease (CAD) related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [118] 0 0
30 days
Secondary outcome [119] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [119] 0 0
90 days
Secondary outcome [120] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [120] 0 0
180 days
Secondary outcome [121] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [121] 0 0
270 days
Secondary outcome [122] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [122] 0 0
1 year
Secondary outcome [123] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [123] 0 0
2 years
Secondary outcome [124] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [124] 0 0
3 years
Secondary outcome [125] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [125] 0 0
4 years
Secondary outcome [126] 0 0
Number of Participants With Rehospitalization - CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Timepoint [126] 0 0
5 years
Secondary outcome [127] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [127] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [128] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [128] 0 0
30 days
Secondary outcome [129] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [129] 0 0
90 days
Secondary outcome [130] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [130] 0 0
180 days
Secondary outcome [131] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [131] 0 0
270 days
Secondary outcome [132] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [132] 0 0
1 year
Secondary outcome [133] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [133] 0 0
2 years
Secondary outcome [134] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [134] 0 0
3 years
Secondary outcome [135] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [135] 0 0
4 years
Secondary outcome [136] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [136] 0 0
5 years
Secondary outcome [137] 0 0
Landmark Analysis on MACE and TVF and Their Components
Timepoint [137] 0 0
3-4 years
Secondary outcome [138] 0 0
Landmark Analysis on MACE and TVF and Their Components
Timepoint [138] 0 0
3-5 years
Secondary outcome [139] 0 0
Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Timepoint [139] 0 0
3-4 years
Secondary outcome [140] 0 0
Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Timepoint [140] 0 0
3-5 years
Secondary outcome [141] 0 0
Number of Participants With Target Lesion Failure (TLF) - The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)
Timepoint [141] 0 0
1 year
Secondary outcome [142] 0 0
Number of Participants With Cumulative Stent/Scaffold Thrombosis - Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Timepoint [142] 0 0
0 to 30 Days

Eligibility
Key inclusion criteria
General

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

2. Subject or a legally authorized representative must provide written Informed Consent
prior to any study related procedure, per site requirements.

3. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or
unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation
MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after
symptom onset if eligibility criteria are otherwise met. Patients with acute coronary
syndrome can be enrolled under the following conditions:

1. Unstable angina or NSTEMI within 2 weeks of the index procedure.

2. STEMI > 72 hours = 2 weeks prior to the index procedure.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the
index procedure can be included in the trial but should be categorized based on their
current angina class.

4. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and
< 70% diameter stenosis must have objective signs of ischemia as determined by one of
the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG),
positron emission tomography (PET), magnetic resonance imaging (MRI), and/or
fractional flow reserve (FFR).

(Note: subject with silent ischemia must have a prior history of typical angina,
angina-equivalent symptoms, or atypical angina within the past year to be included in
the trial.)

5. Subject must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.

6. Female subject of childbearing potential who does not plan pregnancy for up to 1 year
following the index procedure. For a female subject of childbearing potential a
pregnancy test must be performed with negative results known within 7 days prior to
the index procedure per site standard.

7. Female subject is not breast-feeding at the time of the screening visit and will not
be breast-feeding for at least 1 year following the index procedure.

8. Subject agrees to not participate in any other investigational or invasive clinical
study for a period of 5 years following the index procedure.

Angiographic

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a
maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it
must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion
treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions
must be at least 15 mm apart per visual estimation; otherwise this is considered as a
single target lesion for lesion (and stent) length determination and must be treated with a
single study device.

1. Target lesion(s) must be located in a native coronary artery with a visually estimated
or quantitatively assessed %DS of =50% and < 100%, with a thrombolysis in myocardial
infarction (TIMI) flow of = 1, and one of the following: stenosis = 70%, an abnormal
functional test (e.g., fractional flow reserve =0.80 AND/OR a positive stress test), or
presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of
index procedure, or STEMI >72 hours but = 2 weeks prior to the index procedure).

1. Target lesion(s) must be located in a native coronary artery with reference vessel
diameter (RVD) by visual estimation of = 2.50 mm and = 3.75 mm.

2. Target lesion(s) must be located in a native coronary artery with length by visual
estimation of = 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the
index procedure can be included in the trial but should be categorized based on their
current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that
based on visual angiographic assessments, the distal reference vessel diameter is = 2.75 mm
such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it
is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or
optical coherence tomography) is used and demonstrates that the measured distal RVD for
this target lesion is = 2.50 mm (by at least one of these imaging modalities). This
measurement may be performed before or after pre-dilatation, but before randomization. If
the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a
lesion may be treated as a non-target lesion.

General
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12
receptor inhibitor is planned within 12 months after the procedure.

2. 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.

3. Subject has known allergic reaction, hypersensitivity or contraindication to any of
the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and
bivalirudin, and therefore cannot be adequately treated with study medications.

4. Subject had an acute STEMI (appropriate clinical syndrome with =1 mm of ST-segment
elevation in =2 contiguous leads) within 72 hours of the index procedure.

5. Subject has a cardiac arrhythmia identified at the time of screening for which at
least one of the following criteria is met:

1. Subject requires coumadin or any other agent for chronic oral anticoagulation.

2. Subject is likely to become hemodynamically unstable due to their arrhythmia.

3. Subject has poor survival prognosis due to their arrhythmia.

6. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any
quantitative method, including but not limited to echocardiography, MRI,
multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc.
LVEF may be obtained within 6 months prior to the procedure for subjects with stable
CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed
within 1 week of the index procedure and after ACS presentation, which may include
contrast left ventriculography during the index procedure but prior to randomization
in order to confirm the subject's eligibility.

7. Subject has undergone prior PCI within the target vessel during the last 12 months.
Prior PCI within the non-target vessel or any peripheral intervention is acceptable if
performed anytime >30 days before the index procedure, or between a minimum of 24
hours and 30 days before the index procedure if successful and uncomplicated.

8. Subject requires future staged PCI of any lesion other than a target lesion identified
at the time of index procedure; or subject requires future peripheral vascular
interventions < 30 days after the index procedure.

9. Subject has received any solid organ transplants or is on a waiting list for any solid
organ transplants.

10. At the time of screening, the subject has a malignancy that is not in remission.

11. Subject is receiving immunosuppressant therapy or has known immunosuppressive or
severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human
immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are
not included as immunosuppressant therapy.

12. Subject has previously received or is scheduled to receive radiotherapy to a coronary
artery (vascular brachytherapy), or the chest/mediastinum.

13. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin,
dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any
reason).

14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

15. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or
Child-Pugh = Class B.

16. Subject has renal insufficiency as defined as an estimated glomerular filtration rate
(GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.

17. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis
or coagulopathy; has had a significant gastrointestinal or significant urinary bleed
within the past six months.

18. Subject has had a cerebrovascular accident or transient ischemic neurological attack
(TIA) within the past six months, or any prior intracranial bleed, or any permanent
neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous
malformation, etc.).

19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath
insertion. Note: femoral arterial disease does not exclude the patient if radial
access may be used.

20. Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.

21. Subject is in the opinion of the Investigator or designee, unable to comply with the
requirements of the study protocol or is unsuitable for the study for any reason. This
includes completion of Patient Reported Outcome instruments.

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

23. Subject is part of a vulnerable population who, in the judgment of the investigator,
is unable to give Informed Consent for reasons of incapacity, immaturity, adverse
personal circumstances or lack of autonomy. This may include: Individuals with a
mental disability, persons in nursing homes, children, impoverished persons, persons
in emergency situations, homeless persons, nomads, refugees, and those incapable of
giving informed consent. Vulnerable populations also may include members of a group
with a hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention.

Angiographic

All exclusion criteria apply to the target lesion(s) or target vessel(s).

1. Unsuccessful pre-dilatation, defined as the presence of one or more of the following
(note: successful pre-dilatation of at least one target lesion is required prior to
randomization):

1. Residual %diameter stenosis (DS) after pre-dilatation is = 40% (per visual
estimation). Note: achieving a %DS = 20% prior to randomization is strongly
recommended.

2. TIMI flow grade <3 (per visual estimation).

3. Any angiographic complication (e.g. distal embolization, side branch closure).

4. Any dissection NHLBI grade D-F.

5. Any chest pain lasting > 5 minutes.

6. Any ST-segment depression or elevation lasting > 5 minutes.

2. Lesion is located in left main or there is a =30% diameter stenosis in the left main
(unless the left main lesion is a protected left main (i.e. a patent bypass graft to
the LAD and/or LCX arteries is present), and there is no intention to treat the
protected left main lesion).

3. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).

4. Lesion located within 3 mm of the origin of the left anterior descending artery (LAD)
or left circumflex artery (LCX).

5. Lesion involving a bifurcation with a:

1. side branch = 2 mm in diameter, or

2. side branch with either an ostial or non-ostial lesion with diameter stenosis
>50%, or

3. side branch requiring dilatation

6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or
XIENCE stent:

1. Extreme angulation (= 90°) proximal to or within the target lesion.

2. Excessive tortuosity (= two 45° angles) proximal to or within the target lesion.

3. Moderate or heavy calcification proximal to or within the target lesion. If
intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in
the vessel prior to the lesion or within the lesion is = 180°.

7. Lesion or vessel involves a myocardial bridge.

8. Vessel has been previously treated with a stent and the target lesion is within 5 mm
proximal or distal to a previously stented lesion.

9. Target lesion located within an arterial or saphenous vein graft or distal to any
arterial or saphenous vein graft.

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
Active, not 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,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Prince of Wales Public Hospital - Randwick
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Brisbane Womens - Herston
Recruitment hospital [5] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Epworth Healthcare Hospital - Richmond
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3121 - Richmond
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
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
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
South Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Germany
State/province [38] 0 0
Baden-Württemberg
Country [39] 0 0
Germany
State/province [39] 0 0
Bavaria
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Hesse
Country [42] 0 0
Germany
State/province [42] 0 0
Lower Saxony
Country [43] 0 0
Germany
State/province [43] 0 0
North Rhine-Westphalia
Country [44] 0 0
Germany
State/province [44] 0 0
Rhineland-Palatinate
Country [45] 0 0
Germany
State/province [45] 0 0
Schleswig-Holstein

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

Ethics approval
Ethics application status

Summary
Brief summary
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind,
multi-center study, registering approximately 2610 subjects from approximately 140 sites in
the United States and outside the United States. ABSORB IV is a continuation of ABSORB III
(NCT01751906) trial which are maintained under one protocol because both trial designs are
related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV
primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the
safety and effectiveness as well as the potential short and long-term benefits of Abbott
Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
(once commercially available), as compared to the commercially approved, control stent
XIENCE.
Trial website
https://clinicaltrials.gov/show/NCT02173379
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregg W Stone, MD
Address 0 0
Columbia University Medical Center, New York, NY
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications