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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
812
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation
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).
Time frame: ≤ 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.
Time frame: 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).
Time frame: 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).
Time frame: 0 to 1 year
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, Argentina
Eastern Heart Clinic, The Prince of Wales Hospital
Randwick, New South Wales, Australia
Wesley Hospital
Auchenflower, Queensland, Australia
St. Vincent's Hospital
Melbourne, Victoria, Australia
Monash Medical Center
Melbourne, Victoria, Australia
Allgemeines Krankenhaus Linz
Linz, Austria
Onze-Lieve VrouweZiekenhuis
Aalst, Belgium
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
São Paulo, Brazil
Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Instituto Coração Triângulo Mineiro
Uberlândia, Brazil
...and 46 more locations
Time frame: 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.
Time frame: 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.
Time frame: ≤ 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
Time frame: ≤ 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.
Time frame: ≤ 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.
Time frame: ≤ 7 days post index procedure (In-hospital )
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 )
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 0 to 30 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 0 to 180 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 0 to 1 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 0 to 2 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 0 to 3 years
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 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.
Time frame: ≤ 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0 to 3 years
Area Stenosis (%)
Time frame: 18 months
Minimum Lumen Area
Time frame: 18 months
Mean Vessel Area
Time frame: 18 months
Minimum Vessel Area
Time frame: 18 months
Maximum Vessel Area
Time frame: 18 months
Mean Lumen Area
Time frame: 18 months
Maximum Lumen Area
Time frame: 18 months
Mean Plaque Area
Time frame: 18 months
Minimum Plaque Area
Time frame: 18 months
Maximum Plaque Area
Time frame: 18 months
Mean Reference Area
Time frame: 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.
Time frame: 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).
Time frame: 18 months