AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population

Number of Participants With Any Death/Any MI/Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 4 years

Number of Participants With Any Death/Any MI/Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Time frame: 5 years

Number of Participants With 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 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 month

Number of Participants With 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: 6 months

Number of Participants With 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 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 years

Number of Participants With 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 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 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 Target Lesion Failure (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: ≤ 7 days post index procedure (In-hospital )

Number of Participants With Target Lesion Failure (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 1 month

Number of Participants With Target Lesion Failure (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Time frame: 6 months

Number of Participants With Target Lesion Failure (TLF)

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)

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)

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)

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 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: ≤ 7 days post index procedure (In-hospital )

Number of Participants With 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 month

Number of Participants With 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: 6 months

Number of Participants With 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 With 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 With 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 With 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 With 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 All 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: ≤ 7 days post index procedure (In-hospital )

Number of Participants With All 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 month

Number of Participants With All 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: 6 months

Number of Participants With All 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 All 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 All 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 All 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 All 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 Ischemia-driven TVR (ID-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: ≤ 7 days post index procedure (In-hospital )

Number of Participants With Ischemia-driven TVR (ID-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 month

Number of Participants With Ischemia-driven TVR (ID-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: 6 months

Number of Participants With Ischemia-driven TVR (ID-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 Ischemia-driven TVR (ID-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 Ischemia-driven TVR (ID-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 Ischemia-driven TVR (ID-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 Ischemia-driven TVR (ID-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 All 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: ≤ 7 days post index procedure (In-hospital )

Number of Participants With All 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 month

Number of Participants With All 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: 6 months

Number of Participants With All 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 All 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 All 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 All 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 All 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 Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: ≤ 7 days post index procedure (In-hospital )

Number of Participants With Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: 1 month

Number of Participants With Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: 6 months

Number of Participants With Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: 1 year

Number of Participants With Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: 2 years

Number of Participants With Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: 3 years

Number of Participants With Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: 4 years

Number of Participants With Ischemia-driven Revascularization (ID-TLR)

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Time frame: 5 years

Number of Participants Experiencing All 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 study 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 Participants Experiencing All 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 study 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 month

Number of Participants Experiencing All 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 study 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: 6 months

Number of Participants Experiencing All 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 study 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)

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 study 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)

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 study 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)

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 study 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)

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 study 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 ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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: ≤ 7 days post index procedure (In-hospital )

Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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 month

Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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: 6 months

Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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 ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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 ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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 ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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 ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-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 Vessel MI (TV-MI)

Time frame: ≤ 7 days post index procedure (In-hospital )

Number of Participants With Target Vessel MI (TV-MI)

Time frame: 1 month

Number of Participants With Target Vessel MI (TV-MI)

Time frame: 6 months

Number of Participants With Target Vessel MI (TV-MI)

Time frame: 1 year

Number of Participants With Target Vessel MI (TV-MI)

Time frame: 2 years

Number of Participants With Target Vessel MI (TV-MI)

Time frame: 3 years

Number of Participants With Target Vessel MI (TV-MI)

Time frame: 4 years

Number of Participants With Target Vessel MI (TV-MI)

Time frame: 5 years

Number of Participants With Stent/Scaffold Thrombosis

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: Acute (≤ 1 day)

Number of Participants With Stent/Scaffold Thrombosis

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: Subacute (>1 - 30 days)

Number of Participants With Stent/Scaffold Thrombosis

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: Late (31 - 365 days)

Number of Participants With Stent/Scaffold Thrombosis

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: Very Late (366 - 730 days)

Number of Participants With Stent/Scaffold Thrombosis

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: Very Late (731 - 1095 days)

Number of Participants With Stent/Scaffold Thrombosis

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: Very Late (1096 - 1460 days)

Number of Participants With Stent/Scaffold Thrombosis

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Time frame: Very Late (1461 - 1825 days)

In-segment Late Loss (Non-inferiority)

Time frame: 13 months

Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)

Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.

Time frame: 2 years

Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation

Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG)

Time frame: 2 years

Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)

Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.

Time frame: 2 years

Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)

Time frame: 5 years

Number of Participants With Not Ischemia-driven TLR (NID-TLR)

Time frame: 5 years

Number of Participants With Non-Target Vessel MI (NTV-MI)

Time frame: 5 years