XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Time frame: Time Frame: Acute (0-24 hours)

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).

Time frame: Late (>30 days to 1 year)

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).

Time frame: Subacute (>24 hours to 30 days)

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

The difference between post- and pre-procedural MLD.

Time frame: 8 months post index procedure

Late loss is calculated as MLD post procedure - MLD at follow-up.

Time frame: 8 months post index procedure

Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).

Time frame: 8 months post index procedure

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 post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) 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: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) 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 post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) 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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) 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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) 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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Time frame: 3 years post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven 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.

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven 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.

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven 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.

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven 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.

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven 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.

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

Time frame: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

Time frame: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

Time frame: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

Time frame: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

Time frame: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

The value calculated as 100 \* (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

Time frame: Baseline

The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Time frame: Post procedure

The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Time frame: 8 months post index procedure

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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: Participants will be followed for the duration of hospital stay, an average of 5 days

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.~Implant Success rate is calculated per stent base.

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 (less than or equal to 7 days).

Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.~Procedural Success rate is calculated per lesion base.