Back to resultsABSORB EXTEND Clinical Investigation (ABSORB EXTEND)
Primary Purpose
Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ABSORB BVS
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Drug eluting stent, Stents, Angioplasty, Bioabsorbable, Bioresorbable, Scaffold
Eligibility Criteria
Inclusion Criteria:
- Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
- Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
- Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
- If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
- 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.
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 and/or 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).
Sites / Locations
- Instituto Cardiovascular de Buenos Aires-ICBA
- Eastern Heart Clinic, The Prince of Wales Hospital
- Wesley Hospital
- St. Vincent's Hospital
- Monash Medical Center
- Allgemeines Krankenhaus Linz
- Onze-Lieve VrouweZiekenhuis
- Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
- Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
- Instituto Coração Triângulo Mineiro
- Montreal Heart Institute
- University of Ottawa Heart Institute
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
- St. Michael's Hospital
- Prince of Wales Hospital
- Queen Mary Hospital
- Århus University Hospital
- Institut Jacques Cartier (ICPS)
- Clinique Pasteur
- Hopital De Rangueil - CHU
- Charité Berlin Campus Steglitz
- Uni.Klinikum Heidelberg
- Apollo Hospital
- CARE Hospital
- SAL Hospital And Medical Institute
- Care Institute of Medical Sciences
- Madras Medical Mission
- Medanta -The Medicity
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Escorts Heart Institute & Research Centre
- Rabin Medical Center
- Catanzaro University Hospital
- Centro Cardiologico Monzino
- Teikyo University
- Shonan Kamakura General Hospital
- Saiseikai Yokohama City Eastern Hospital
- Kyoto University Hospital
- Mitsui Memorial Hospital
- Institute Jantung Negara
- Catharina ZH Eindhoven
- Erasmus Medical Center
- Maasstad Ziekenhuis
- Mercy Angiography Unit
- Christchurch Hospital
- University Hospital Krakow
- National University Hospital
- Sunninghill Hospital
- Clinico San Carlos
- La Paz
- Hospital do Meixoeiro
- Lund University Hospital
- Inselspital Bern, Kardiologie
- Chang Gung Memorial Hospital
- National Taiwan University Hospital
- Glenfield Hospital
- King's College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABSORB BVS
Arm Description
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Outcomes
Primary Outcome Measures
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Secondary Outcome Measures
Clinical Device Success
Defined as 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 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
Defined as 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.
Number of Participants With 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.
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Number of Participants With 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.
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Number of Participants With 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.
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Number of Participants With 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.
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Number of Participants With 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.
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Number of Participants With 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.
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Number of Participants With Scaffold Thrombosis (Early)
According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis (Late)
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis (Very Late)
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Area Stenosis (%)
Minimum Lumen Area
Mean Vessel Area
Minimum Vessel Area
Maximum Vessel Area
Mean Lumen Area
Maximum Lumen Area
Mean Plaque Area
Minimum Plaque Area
Maximum Plaque Area
Mean Reference Area
Calculated Minimum Lumen Diameter
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Calculated Diameter Stenosis
The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Full Information
NCT ID
NCT01023789
First Posted
November 30, 2009
Last Updated
January 18, 2018
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01023789
Brief Title
ABSORB EXTEND Clinical Investigation
Acronym
ABSORB EXTEND
Official Title
ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System
ABSORB BVS is currently in development at Abbott Vascular.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease
Keywords
Drug eluting stent, Stents, Angioplasty, Bioabsorbable, Bioresorbable, Scaffold
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
812 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABSORB BVS
Arm Type
Experimental
Arm Description
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Intervention Type
Device
Intervention Name(s)
ABSORB BVS
Intervention Description
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation
Primary Outcome Measure Information:
Title
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Time Frame
≤ 7 days post index procedure (In hospital)
Title
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Time Frame
0 to 30 days
Title
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame
0 to 180 days
Title
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame
0 to 1 year
Secondary Outcome Measure Information:
Title
Clinical Device Success
Description
Defined as 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 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.
Time Frame
On day 0 (immediate post-index procedure)
Title
Clinical Procedure Success
Description
Defined as 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.
Time Frame
On day 0 (immediate post-index procedure)
Title
Number of Participants With Cardiac Death
Description
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.
Time Frame
≤ 7 days post index procedure (In-hospital )
Title
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame
≤ 7 days post index procedure (In-hospital )
Title
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
≤ 7 days post index procedure (In-hospital )
Title
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
≤ 7 days post index procedure (In-hospital )
Title
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time Frame
≤ 7 days post index procedure (In-hospital )
Title
Number of Participants With Cardiac Death
Description
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.
Time Frame
0 to 30 days
Title
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame
0 to 30 days
Title
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 30 days
Title
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 30 days
Title
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time Frame
0 to 30 days
Title
Number of Participants With Cardiac Death
Description
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.
Time Frame
0 to 180 days
Title
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame
0 to 180 days
Title
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 180 days
Title
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 180 days
Title
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time Frame
0 to 180 days
Title
Number of Participants With Cardiac Death
Description
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.
Time Frame
0 to 1 year
Title
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame
0 to 1 year
Title
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 1 year
Title
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 1 year
Title
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time Frame
0 to 1 year
Title
Number of Participants With Cardiac Death
Description
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.
Time Frame
0 to 2 year
Title
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame
0 to 2 year
Title
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 2 year
Title
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 2 year
Title
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time Frame
0 to 2 year
Title
Number of Participants With Cardiac Death
Description
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.
Time Frame
0 to 3 years
Title
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame
0 to 3 years
Title
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
Revascularization at the target lesion associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 3 years
Title
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
Revascularization in the target vessel associated with any of the following:
Positive functional ischemia study.
Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame
0 to 3 years
Title
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time Frame
0 to 3 years
Title
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame
≤ 7 days post index procedure (In hospital)
Title
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame
0 to 30 days
Title
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame
0 to 180 days
Title
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame
0 to 1 year
Title
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame
0 to 2 years
Title
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description
The composite endpoint composed of
Cardiac death,
Myocardial infarction (Q wave and Non-Q wave),
Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame
0 to 3 years
Title
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame
0 to 2 years
Title
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame
0 to 3 years
Title
Number of Participants With Scaffold Thrombosis (Early)
Description
According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame
0 to 30 days
Title
Number of Participants With Scaffold Thrombosis
Description
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame
0 to 180 days
Title
Number of Participants With Scaffold Thrombosis (Late)
Description
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame
31 - 365 days
Title
Number of Participants With Scaffold Thrombosis
Description
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame
0 to 1 year
Title
Number of Participants With Scaffold Thrombosis (Very Late)
Description
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame
366 days to 2 years
Title
Number of Participants With Scaffold Thrombosis
Description
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame
0 to 2 years
Title
Number of Participants With Scaffold Thrombosis
Description
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame
0 to 3 years
Title
Area Stenosis (%)
Time Frame
18 months
Title
Minimum Lumen Area
Time Frame
18 months
Title
Mean Vessel Area
Time Frame
18 months
Title
Minimum Vessel Area
Time Frame
18 months
Title
Maximum Vessel Area
Time Frame
18 months
Title
Mean Lumen Area
Time Frame
18 months
Title
Maximum Lumen Area
Time Frame
18 months
Title
Mean Plaque Area
Time Frame
18 months
Title
Minimum Plaque Area
Time Frame
18 months
Title
Maximum Plaque Area
Time Frame
18 months
Title
Mean Reference Area
Time Frame
18 months
Title
Calculated Minimum Lumen Diameter
Description
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Time Frame
18 months
Title
Calculated Diameter Stenosis
Description
The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
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.
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 and/or 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Abizaid, MD
Organizational Affiliation
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Serruys, MD
Organizational Affiliation
Thoraxcenter-Erasmus University
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Cardiovascular de Buenos Aires-ICBA
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Eastern Heart Clinic, The Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Wesley Hospital
City
Auchenflower
State/Province
Queensland
Country
Australia
Facility Name
St. Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Monash Medical Center
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Allgemeines Krankenhaus Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Onze-Lieve VrouweZiekenhuis
City
Aalst
Country
Belgium
Facility Name
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
City
Sao Paulo
ZIP/Postal Code
04012-180
Country
Brazil
Facility Name
Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05652-901
Country
Brazil
Facility Name
Instituto Coração Triângulo Mineiro
City
Uberlandia
ZIP/Postal Code
38400-368
Country
Brazil
Facility Name
Montreal Heart Institute
City
Montreal
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Århus University Hospital
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Institut Jacques Cartier (ICPS)
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Hopital De Rangueil - CHU
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Charité Berlin Campus Steglitz
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Uni.Klinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Apollo Hospital
City
Hyderabaad
State/Province
Andhar Pradesh
ZIP/Postal Code
500033
Country
India
Facility Name
CARE Hospital
City
Hyderabaad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
SAL Hospital And Medical Institute
City
Ahmedabad
ZIP/Postal Code
380054
Country
India
Facility Name
Care Institute of Medical Sciences
City
Ahmedabad
ZIP/Postal Code
380060
Country
India
Facility Name
Madras Medical Mission
City
Chennai
ZIP/Postal Code
600 037
Country
India
Facility Name
Medanta -The Medicity
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Sanjay Gandhi Postgraduate Institute of Medical Sciences
City
Lucknow
ZIP/Postal Code
226014
Country
India
Facility Name
Escorts Heart Institute & Research Centre
City
New Delhi
ZIP/Postal Code
110 070
Country
India
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Catanzaro University Hospital
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milano
Country
Italy
Facility Name
Teikyo University
City
Tokyo
State/Province
Itabashi
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Saiseikai Yokohama City Eastern Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
State/Province
Kansai
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Chiyoda-ku
ZIP/Postal Code
101-8643
Country
Japan
Facility Name
Institute Jantung Negara
City
Kuala Lumpur
Country
Malaysia
Facility Name
Catharina ZH Eindhoven
City
Eindhoven
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Mercy Angiography Unit
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
University Hospital Krakow
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Sunninghill Hospital
City
Johannesburg
Country
South Africa
Facility Name
Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
La Paz
City
Madrid
Country
Spain
Facility Name
Hospital do Meixoeiro
City
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Inselspital Bern, Kardiologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30286520
Citation
Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4.
Results Reference
derived
PubMed Identifier
29699614
Citation
Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051.
Results Reference
derived
PubMed Identifier
26585622
Citation
Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.
Results Reference
derived
PubMed Identifier
24769555
Citation
Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243.
Results Reference
derived
PubMed Identifier
24746650
Citation
Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
Results Reference
derived
PubMed Identifier
23866188
Citation
Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008. No abstract available.
Results Reference
derived
PubMed Identifier
23517836
Citation
Muramatsu T, Onuma Y, Garcia-Garcia HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.
Results Reference
derived
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ABSORB EXTEND Clinical Investigation
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