To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
480
Subjects receiving XIENCE V
Subjects receiving Absorb BVS System
Abbott Vascular
Santa Clara, California, United States
In-segment Late Loss (LL) - Per Subject Analysis
In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
Time frame: 1 year
In-segment Late Loss (LL) - Per Lesion Analysis
In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
Time frame: 1 year
Acute Device Success
Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.
Time frame: < or = 1 day
Number of Participants With Acute Procedural Success
Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.
Time frame: At time of procedure up to 7 days in hospital
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 37days
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 208 days
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 298 days
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 1 year
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 2 year
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 3 years
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 4 years
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Time frame: 5 years
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 0 to 37 days
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 0 to 208 days
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 0 to 298 days
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 1 year
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 2 year
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 3 years
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 4 years
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 5 years
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 0 to 37 days
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 0 to 208 days
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 0 to 298 days
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 1 year
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 2 year
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 3 years
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 4 years
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 5 years
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 0 to 37 days
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 0 to 208 days
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 0 to 298 days
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 1 year
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 2 year
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 3 years
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 4 years
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 5 years
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 0 to 37days
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 0 to 208 days
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 0 to 298 Days
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 1 year
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 2 year
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 3 years
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 4 years
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 5 years
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 37 days
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 208 days
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 298 days
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 1 year
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 2 year
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 3 years
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 4 years
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 5 years
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 0 to 37 days
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 0 to 208 days
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 0 to 298 days
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 1 year
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 2 year
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 3 years
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 4 years
Number of Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Time frame: 5 years
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 37 days
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 208 days
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 298 days
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 1 year
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 2 year
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 3 years
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 4 years
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 5 years
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 0 to 37 days
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 0 to 208 days
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 0 to 298 days
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 1 year
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 2 year
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 3 years
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 4 years
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 5 years
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: ≤ 7 days post index procedure (In-hospital)
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 37 days
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 208 days
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 298 days
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 1 year
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 2 year
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 3 years
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 4 years
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 5 years
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 37 days
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 208 days
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 298 days
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 1 year
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 2 year
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 3 years
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 4 years
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 5 years
Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: < or = 1 day
Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: >1 to 30 days
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 31 to 365 days
Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 366 to 730 days
Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 731 to 1095 days
Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 366-1095 days
Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 1096-1460 days
Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 1461-1825 days
Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 1096-1825 days
Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 0-1825 days
In-Device Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time frame: 1 year
In-Segment Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.
Time frame: 1 year
Proximal Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time frame: 1 year
Distal Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time frame: 1 year
In-Segment Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
In-Device Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
Proximal Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time frame: 1 year
Distal Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.
Time frame: 1 year
Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time frame: 1 year
In-Segment Late Loss (LL)
In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).
Time frame: 1 year
Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time frame: 1 year
In-Device Late Loss (LL)
In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).
Time frame: 1 year
Proximal Late Loss (LL)
Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.
Time frame: 1 year
Distal Late Loss (LL)
Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement.
Time frame: 1 year
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