Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000131055
Ethics application status
Approved
Date submitted
27/01/2010
Date registered
9/02/2010
Date last updated
28/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Continuation in the Clinical
Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable
Vascular Scaffold in the Treatment of Subjects With de Novo Native
Coronary Artery Lesions
Scientific title
ABSORB EXTEND A Continuation in the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable
Vascular Scaffold in the Treatment of Subjects With de Novo Native
Coronary Artery Lesions
Secondary ID [1] 1310 0
ClinicalTrials.gov: NCT01023789
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Ischemia 256604 0
Coronary Artery Stenosis 256752 0
Coronary Disease 256753 0
Coronary Artery Disease 256754 0
Coronary Restenosis 256755 0
Cardiovascular Disease 256756 0
Condition category
Condition code
Cardiovascular 256770 256770 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bioresorbable Vascular Solutions Everolimus Eluting Coronary Scaffold System (BVS EECSS). Percutaneous Coronary Intervention (PCI) is commonly known as coronary angioplasty. Typically, PCI is performed by threading a slender balloon-tipped tube, a catheter, from an artery in the groin to a trouble spot in an artery of the heart. The balloon is then inflated, compressing the plaque and dilating (widening) the narrowed coronary artery so that blood can flow more easily. During PCI for this study, the BVS EECSS is then placed in the coronary artery to support the previously narrowed area. The BVS EECSS will remain in place until the bioresorbtion process is complete, your physician will discuss this process with you. The duration of the PCI procedure will depend on many factors, and is typically less than 2 hours. Your physician will discuss those factors and the length of your procedure with you. Optical Coherence Tomography (OCT) subgroup definition: - A subgroup of up to 50 subjects who: - Have their procedures performed at selected investigational sites with OCT capability; and - Receive planned overlapping BVS treatment of the target lesion. - The need for planned overlapping of BVS will be determined by the investigator up to the time of the index procedure. - Angiography, Intravascular Ultrasound (IVUS) and OCT are required for all subjects in the OCT subgroup post-procedure and at 2-year follow-up Multi-Slice Computed Tomography subgroup definition: - A subgroup of up to 100 subjects who: - Have their procedures performed at selected investigational sites having both OCT and MSCT capability; and - Receive at least one BVS EECSS in the target lesion. MSCT imaging and clinical follow-up at 18 months is required for all subjects in the MSCT subgroup.
Intervention code [1] 255861 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257664 0
(This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure). Acute Success is classified according to the following definitions: Clinical Device Success Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by Qualitative Coronary Angiography (QCA) (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met. Clinical Procedure Success Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [1] 257664 0
Acute: From time time of insertion of the device to hospital discharge.
Secondary outcome [1] 262940 0
Cardiac Death (CD): Any death due to proximate cardiac cause (e.g., myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death, death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [1] 262940 0
30, 180 days, and 1, 2, and 3 years following BVS EECSS procedure. Subjects in the Multi-Slice Computed Tomography (MSCT) subgroup will also have clinical follow-up at 18 months.
Secondary outcome [2] 262941 0
Myocardial Infarction (MI):
Q wave MI
Development of new, pathological Q wave on the Electrocardiogram (ECG)

Non-Q wave MI
Elevation of Creatine Kinase (CK) levels to greater than or equal to two times the upper limit of normal (ULN) with elevated Creatine Kinase-Myocardial Band (CK-MB) in the absence of new pathological Q waves.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [2] 262941 0
30, 180 days, and 1, 2, and 3 years following BVS EECSS procedure.
Secondary outcome [3] 262942 0
Target Vessel Myocardial Infarction (TV-MI): Please see "MI" in outcome #2. An MI which originates in the target vessel (vessel to be treated) based on information entered by site personnel.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [3] 262942 0
30, 180 days, and 1, 2, and 3 years following BVS EECSS procedure.
Secondary outcome [4] 262943 0
Ischemia Driven Major Adverse Cardiac Events (ID MACE):
The composite endpoint composed of
cardiac death,
myocardial infarction (MI)
ischemia-driven target lesion revascularization (TLR)

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [4] 262943 0
30, 180 days, and 1, 2, and 3 years following BVS EECSS procedure.
Secondary outcome [5] 262944 0
Ischemia driven Target Vessel Failure (ID TVF): Any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [5] 262944 0
30, 180 days, and 1, 2, and 3 years following BVS EECSS procedure.
Secondary outcome [6] 262945 0
Ischemia Driven Target Lesion Revascularization (ID TLR): 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.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [6] 262945 0
30, 180 days and 1, 2, and 3 years following BVS EECSS procedure.
Secondary outcome [7] 262946 0
Ischemia Driven Target Vessel Revascularization (ID TVR): Any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [7] 262946 0
30, 180 days and 1, 2, and 3 years following BVS EECSS procedure.
Secondary outcome [8] 262947 0
Scaffold thrombosis: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis. In the absence of angiography, any unexplained death, or acute MI in the distribution of the target lesion within 30 days This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [8] 262947 0
30, 180 days, and 1, 2, and 3 years following BVS EECSS procedure.
Secondary outcome [9] 262948 0
Descriptive analysis of strut, lesion and vessel morphology post-procedure by Optical Coherence Tomography (OCT), which is a catheter based optical imaging modality used in Percutaneous Coronary Intervention (PCI).

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [9] 262948 0
2 years following BVS EECSS procedure
Secondary outcome [10] 262949 0
Scaffold area post-procedure assessed by Optical Coherence Tomography (OCT), which is a catheter based optical imaging modality used in PCI. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [10] 262949 0
2 years following BVS EECSS procedure.
Secondary outcome [11] 262950 0
Lumen area assessed by Optical Coherence Tomography (OCT), which is a catheter based optical imaging modality used in PCI.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [11] 262950 0
post-procedure and at 2 years following BVS EECSS procedure.
Secondary outcome [12] 262951 0
Minimum luminal area (MLA) assessed by Optical Coherence Tomography (OCT), which is a catheter based optical imaging modality used in PCI.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [12] 262951 0
post-procedure and at 2 years following BVS EECSS procedure.
Secondary outcome [13] 262952 0
Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition assessed by Optical Coherence Tomography (OCT), which is a catheter based optical imaging modality used in PCI.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [13] 262952 0
2 years (if analyzable) following BVS EECSS procedure.
Secondary outcome [14] 262953 0
Treated site Late Loss (LL) assessed by Angiography done for patients within the OCT subgroup. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [14] 262953 0
2 years following BVS EECSS procedure.
Secondary outcome [15] 262954 0
In-segment LL assessed by Angiography done for patients within the OCT subgroup.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [15] 262954 0
2 years following BVS EECSS procedure.
Secondary outcome [16] 262955 0
Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement) assessed by Angiography done for patients within the OCT subgroup. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [16] 262955 0
2 years following BVS EECSS procedure.
Secondary outcome [17] 262956 0
Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement) assessed by Angiography done for patients within the OCT subgroup. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [17] 262956 0
2 years following BVS EECSS procedure.
Secondary outcome [18] 262957 0
Treated site and treated segment Minimum Luminal Diameter (MLD) assessed by Angiography done for patients within the OCT subgroup. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [18] 262957 0
post-procedure and at 2 years following BVS EECSS procedure.
Secondary outcome [19] 262958 0
Treated site and treated segment % Diameter Stenosis (DS) assessed by Angiography done for patients within the OCT subgroup. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [19] 262958 0
post-procedure and at 2 years following BVS EECSS procedure.
Secondary outcome [20] 262959 0
Treated site and treated segment Angiographic Binary Restenosis (ABR) rate assessed by Angiography done for patients within the OCT subgroup. This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [20] 262959 0
2 years following BVS EECSS procedure.
Secondary outcome [21] 262960 0
Aneurysm, thrombus, persisting dissection assessed by Angiography done for patients within the OCT subgroup.

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [21] 262960 0
2 years following BVS EECSS procedure.
Secondary outcome [22] 262961 0
Vessel area assessed by Intravscular Ultrasound (IVUS) done for patients within the OCT subgroup. (IVUS is a catheter based ultrasound imaging modality used in PCI.)

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [22] 262961 0
post-procedure and at 2 years following BVS EECSS procedure'.
Secondary outcome [23] 262962 0
Scaffold area post-procedure and (if analyzable) assessed by Intravscular Ultrasound (IVUS) done for patients within the OCT subgroup. (IVUS is a catheter based ultrasound imaging modality used in PCI.) This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential
Timepoint [23] 262962 0
2 years following BVS EECSS procedure.
Secondary outcome [24] 262963 0
Minimum luminal area (MLA) assessed by Intravscular Ultrasound (IVUS) done for patients within the OCT subgroup. (IVUS is a catheter based ultrasound imaging modality used in PCI.)

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [24] 262963 0
post-procedure and at 2 years following BVS EECSS procedure.
Secondary outcome [25] 262964 0
Treated site %Volume Obstruction (VO) assessed by Intravscular Ultrasound (IVUS) done for patients within the OCT subgroup. (IVUS is a catheter based ultrasound imaging modality used in PCI.) This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [25] 262964 0
2 years following BVS EECSS procedure.
Secondary outcome [26] 262965 0
Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition assessed by Intravscular Ultrasound (IVUS) done for patients within the OCT subgroup. (IVUS is a catheter based ultrasound imaging modality used in PCI.)

This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [26] 262965 0
2 years (if analyzable) following BVS EECSS procedure.
Secondary outcome [27] 262966 0
Descriptive analysis of vascular and scaffold morphology using Multi-Slice Computed Tomography (MSCT) This data is entered into electronic case report forms by investigational site personnel, personal information is kept confidential.
Timepoint [27] 262966 0
18 months following BVS EECSS procedure.

Eligibility
Key inclusion criteria
Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.

Target lesion(s) must measure <= 28 mm in length by Qualitative Coronary Angiography (QCA), or by visual estimation if on line QCA is not available.

Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a Thrombolysis in Myocardial Infarction (TIMI) flow of >= 1.

If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels.

Percutaneous interventions for lesions in a non-target vessel are allowed if done >= 30 days prior to or if planned to be done > 6 months after the index procedure.

Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.


Lesion(s) involving a bifurcation with side branch vessel >= 2 mm in diameter, ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.


Total occlusion (TIMI flow 0), prior to wire passing.


Target vessel(s) contains visible thrombus.


Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).


Subject has received brachytherapy in any epicardial vessel (including side branches).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2420 0
Belgium
State/province [1] 2420 0
Country [2] 2421 0
Brazil
State/province [2] 2421 0
Country [3] 2422 0
France
State/province [3] 2422 0
Country [4] 2423 0
Denmark
State/province [4] 2423 0
Country [5] 2424 0
Netherlands
State/province [5] 2424 0
Country [6] 2425 0
Italy
State/province [6] 2425 0
Country [7] 2426 0
Switzerland
State/province [7] 2426 0
Country [8] 2427 0
Poland
State/province [8] 2427 0
Country [9] 2428 0
India
State/province [9] 2428 0

Funding & Sponsors
Funding source category [1] 256359 0
Commercial sector/Industry
Name [1] 256359 0
Abbott Vascular
Country [1] 256359 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Abbott Vascular
Address
3200 Lakeside Dr.
Santa Clara, Ca. 95054
Country
United States of America
Secondary sponsor category [1] 251678 0
None
Name [1] 251678 0
Address [1] 251678 0
Country [1] 251678 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30730 0
Address 30730 0
Country 30730 0
Phone 30730 0
Fax 30730 0
Email 30730 0
Contact person for public queries
Name 13977 0
Candace Elek
Address 13977 0
3200 Lakeside Dr.
Santa Clara, Ca. 950504
Country 13977 0
United States of America
Phone 13977 0
+1 408-845-3133
Fax 13977 0
Email 13977 0
Candace.Elek@av.abbott.com
Contact person for scientific queries
Name 4905 0
Robert McGreevy
Address 4905 0
3200 Lakeside Dr.
Santa Clara, Ca. 950504
Country 4905 0
United States of America
Phone 4905 0
+1 408-845-3932
Fax 4905 0
Email 4905 0
Robert.Mcgreevy@av.abbott.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.