Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)
In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale in the US.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
501
XIENCE implantation in the treatment of coronary artery disease.
ABSORB BVS implantation in the treatment of coronary artery disease.
Abbott Vascular International BVBA
Brussels, Belgium
Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)
In-scaffold:Within the margins of the scaffold.
Time frame: 3 years
Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter
In-scaffold:Within the margins of the scaffold.
Time frame: 3 years
Device Success
Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).
Time frame: From the start of index procedure to end of index procedure
Number of Participants With Procedural Success
Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay.
Time frame: From the start of index procedure to end of index procedure
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * 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.
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Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 30 days
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 180 Days
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 years
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * 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 Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * 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: 5 years
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - 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 Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - 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 Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.
Time frame: 30 days
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - 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: 180 days
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - 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: 1 year
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - 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: 2 years
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - 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: 3 years
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) * 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: 4 years
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) * 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: 5 years
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 30 days
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 180 days
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 1 year
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 2 years
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 3 years
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 4 years
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 5 years
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 30 days
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 180 days
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 1 year
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 2 years
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 3 years
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 4 years
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 5 years
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 30 days
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 180 days
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 1 year
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 2 years
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 3 years
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 4 years
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.
Time frame: 5 years
Number of Participants With All Revascularization
Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 30 days
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 180 days
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 1 year
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 2 years
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 3 years
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 4 years
Number of Participants With All Revascularization
Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 5 years
Number of Participants Experiencing All 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 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: In-hospital (≤ 7 days of post index procedure)
Number of Participants Experiencing All 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 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: 30 days
Number of Participants Experiencing All 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 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: 180 days
Number of Participants Experiencing All 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: 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: 1 year
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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: 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: 2 years
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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: 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: 3 years
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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: 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: 4 years
Number of Participants Experiencing All 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 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: 5 years
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 30 days
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 180 days
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 1 year
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 2 years
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 3 years
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 4 years
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 5 years
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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: In-hospital (≤ 7 days of post index procedure)
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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: 30 days
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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: 180 days
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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 Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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 years
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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 Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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 Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
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 Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 30 days
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 180 days
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
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 Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 2 years
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
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 Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
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 Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
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 DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization
Time frame: In-hospital (≤ 7 days of post index procedure)
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 30 days
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 180 days
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 1 year
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 2 years
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 3 years
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization
Time frame: 4 years
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization
Time frame: 5 years
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) 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: In-hospital (≤ 7 days of post index procedure)
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * 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: 30 days
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * 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: 180 days
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * 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: 1 year
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * 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: 2 years
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * 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: 3 years
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) 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: 4 years
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) 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: 5 years
Number of Participants With Acute Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.
Time frame: <=1 day
Number of Participants With Subacute Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.
Time frame: > 1-30 days
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.
Time frame: 0-30 days
Number of Participants With Late Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.
Time frame: 31-365 days
Number of Participants With Very Late Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.
Time frame: > 365 days
Number of Participants With Cumulative Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.
Time frame: 0-1853 days