ABSORB EXTEND Clinical Investigation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease

Intervention / Treatment
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* Device: ABSORB BVS


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABSORB BVS<br>Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease | Device: ABSORB BVS<br>* Absorb Bioresorbable Vascular Scaffold (BVS) System implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | ≤ 7 days post index procedure (In hospital) | 
| 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. | 0 to 30 days | 
| 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). | 0 to 180 days | 
| 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). | 0 to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | On day 0 (immediate post-index procedure) | 
| 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. | On day 0 (immediate post-index procedure) | 
| 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. | ≤ 7 days post index procedure (In-hospital ) | 
| 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 | ≤ 7 days post index procedure (In-hospital ) | 
| 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. | ≤ 7 days post index procedure (In-hospital ) | 
| 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. | ≤ 7 days post index procedure (In-hospital ) | 
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |  | ≤ 7 days post index procedure (In-hospital ) | 
| 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. | 0 to 30 days | 
| 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 | 0 to 30 days | 
| 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. | 0 to 30 days | 
| 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. | 0 to 30 days | 
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |  | 0 to 30 days | 
| 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. | 0 to 180 days | 
| 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 | 0 to 180 days | 
| 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. | 0 to 180 days | 
| 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. | 0 to 180 days | 
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |  | 0 to 180 days | 
| 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. | 0 to 1 year | 
| 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 | 0 to 1 year | 
| 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. | 0 to 1 year | 
| 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. | 0 to 1 year | 
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |  | 0 to 1 year | 
| 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. | 0 to 2 year | 
| 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 | 0 to 2 year | 
| 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. | 0 to 2 year | 
| 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. | 0 to 2 year | 
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |  | 0 to 2 year | 
| 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. | 0 to 3 years | 
| 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 | 0 to 3 years | 
| 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. | 0 to 3 years | 
| 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. | 0 to 3 years | 
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |  | 0 to 3 years | 
| 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. | ≤ 7 days post index procedure (In hospital) | 
| 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. | 0 to 30 days | 
| 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. | 0 to 180 days | 
| 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. | 0 to 1 year | 
| 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. | 0 to 2 years | 
| 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. | 0 to 3 years | 
| 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). | 0 to 2 years | 
| 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). | 0 to 3 years | 
| 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. | 0 to 30 days | 
| 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. | 0 to 180 days | 
| 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. | 31 - 365 days | 
| 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. | 0 to 1 year | 
| 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. | 366 days to 2 years | 
| 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. | 0 to 2 years | 
| 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. | 0 to 3 years | 
| Area Stenosis (%) |  | 18 months | 
| Minimum Lumen Area |  | 18 months | 
| Mean Vessel Area |  | 18 months | 
| Minimum Vessel Area |  | 18 months | 
| Maximum Vessel Area |  | 18 months | 
| Mean Lumen Area |  | 18 months | 
| Maximum Lumen Area |  | 18 months | 
| Mean Plaque Area |  | 18 months | 
| Minimum Plaque Area |  | 18 months | 
| Maximum Plaque Area |  | 18 months | 
| Mean Reference Area |  | 18 months | 
| 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. | 18 months | 
| 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). | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting stent, Stents, Angioplasty, Bioabsorbable, Bioresorbable, Scaffold