XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

Coronary Artery Disease Clinical Trial

Official title:

XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721096
• Other study ID #: 12-398
• Status: Completed
• Start date: October 2012
• Est. completion date: November 2018

Study information

• Verified date: May 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

Description:

The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: November 2018
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent

• Patient provides Informed Consent Form

Exclusion Criteria:

• If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.

Related Conditions & MeSH terms

• Angina
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Occlusion
• Coronary Stenosis
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• XIENCE PRIME - Long Length (LL)
Long Length
• XIENCE PRIME - Core Size
Core Size

Locations

Country	Name	City	State
Japan	Abbott Vascular Japan Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Acute Stent Thrombosis (ST)	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: Acute (0-24 hours)
Primary	Number of Participants With Subacute Stent Thrombosis (ST)	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).	Subacute (>24 hours to 30 days)
Primary	Number of Participants With Late Stent Thrombosis (ST)	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).	Late (>30 days to 1 year)
Primary	Total Number of Participants With Overall Stent Thrombosis	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).	1 year post index procedure
Secondary	Success Rate: Percentage of Participants With Implant Success Rate by Device	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).	Participants will be followed for the duration of hospital stay, an average of 5 days
Secondary	Success Rate: Percentage of Participants With Procedural Success by Lesion	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).	Participants will be followed for the duration of hospital stay, an average of 5 days
Secondary	Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)		Participants will be followed for the duration of hospital stay, an average of 5 days
Secondary	Number of Participants With Target Lesion Failure (TLF)	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR	8 months post index procedure
Secondary	Number of Participants With Target Lesion Failure (TLF)	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR	1 year post index procedure
Secondary	Number of Participants With Target Lesion Failure (TLF)	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR	2 year post index procedure
Secondary	Number of Participants With Target Lesion Failure (TLF)	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR	3 years post index procedure
Secondary	Number of Participants With Target Lesion Failure (TLF)	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR	4 year post index procedure
Secondary	Number of Participants With All Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization	8 months post index procedure
Secondary	Number of Participants With All Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization	1 year post index procedure
Secondary	Number of Participants With All Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization	2 year post index procedure
Secondary	Number of Participants With All Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization	3 year post index procedure
Secondary	Number of Participants With All Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization	4 year post index procedure
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).	8 months post index procedure
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).	1 year post index procedure
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).	2 year post index procedure
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).	3 year post index procedure
Secondary	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).	4 year post index procedure
Secondary	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	8 months post index procedure
Secondary	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	1 year post index procedure
Secondary	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	2 year post index procedure
Secondary	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	3 year post index procedure
Secondary	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	4 year post index procedure
Secondary	Number of Participants With Death or Myocardial Infarction (MI)	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	8 months post index procedure
Secondary	Number of Participants With Death or Myocardial Infarction (MI)	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	1 year post index procedure
Secondary	Number of Participants With Death or Myocardial Infarction (MI)	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	2 year post index procedure
Secondary	Number of Participants With Death or Myocardial Infarction (MI)	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	3 year post index procedure
Secondary	Number of Participants With Death or Myocardial Infarction (MI)	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	4 year post index procedure
Secondary	Number of Participants With Cardiac Death or Myocardial Infarction (MI)	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.	8 months post index procedure
Secondary	Number of Participants With Cardiac Death or Myocardial Infarction (MI)	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.	1 year post index procedure
Secondary	Number of Participants With Cardiac Death or Myocardial Infarction (MI)	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.	2 year post index procedure
Secondary	Number of Participants With Cardiac Death or Myocardial Infarction (MI)	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.	3 year post index procedure
Secondary	Number of Participants With Cardiac Death or Myocardial Infarction (MI)	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.	4 year post index procedure
Secondary	Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	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.	8 months post index procedure
Secondary	Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	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.	1 year post index procedure
Secondary	Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	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.	2 year post index procedure
Secondary	Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	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.	3 year post index procedure
Secondary	Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	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.	4 year post index procedure
Secondary	Number of Participants Experienced Death (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	8 months post index procedure
Secondary	Number of of Participants Experienced Death (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	1 year post index procedure
Secondary	Number of Participants Experienced Death (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	2 year post index procedure
Secondary	Number of Participants Experienced Death (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	3 year post index procedure
Secondary	Number of Participants Experienced Death (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	4 year post index procedure
Secondary	Number of Participants With Myocardial Infarction (MI)	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.	8 months post index procedure
Secondary	Number of Participants With Myocardial Infarction (MI)	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.	1 year post index procedure
Secondary	Number of Participants With Myocardial Infarction (MI)	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.	2 year post index procedure
Secondary	Number of Participants With Myocardial Infarction (MI)	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.	3 year post index procedure
Secondary	Number of Participants With Myocardial Infarction (MI)	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.	4 year post index procedure
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	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.	8 months post index procedure
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	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.	1 year post index procedure
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	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.	2 year post index procedure
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	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.	3 year post index procedure
Secondary	Number of Participants With Target Lesion Revascularization(TLR)	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.	4 year post index procedure
Secondary	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.	8 months post index procedure
Secondary	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.	1 year post index procedure
Secondary	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.	2 year post index procedure
Secondary	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.	3 year post index procedure
Secondary	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.	4 year post index procedure
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	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)	8 months post index procedure
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))	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)	1 year post index procedure
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	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)	2 year post index procedure
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	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)	3 year post index procedure
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	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)	4 year post index procedure
Secondary	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.	8 months post index procedure
Secondary	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.	1 year post index procedure
Secondary	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.	2 year post index procedure
Secondary	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.	3 year post index procedure
Secondary	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.	4 year post index procedure
Secondary	Number of Participants With All Revascularization	All revascularization includes ischemia driven and non-ischemia driven revascularization.	8 months post index procedure
Secondary	Number of Participants With All Revascularization	All revascularization includes ischemia driven and non-ischemia driven revascularization.	1 year post index procedure
Secondary	Number of Participants With All Revascularization	All revascularization includes ischemia driven and non-ischemia driven revascularization.	2 year post index procedure
Secondary	Number of Participants With All Revascularization	All revascularization includes ischemia driven and non-ischemia driven revascularization.	3 year post index procedure
Secondary	Number of Participants With All Revascularization	All revascularization includes ischemia driven and non-ischemia driven revascularization.	4 year post index procedure
Secondary	Number of Participants Experienced Bleeding	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	8 months post index procedure
Secondary	Number of Participants Experienced Bleeding	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	1 year post index procedure
Secondary	Number of Participants Experienced Bleeding	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	2 year post index procedure
Secondary	Number of Participants Experienced Bleeding	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	3 year post index procedure
Secondary	Number of Participants Experienced Bleeding	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	4 year post index procedure
Secondary	Percent Diameter Stenosis (%DS)	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).	Baseline
Secondary	Percent Diameter Stenosis (%DS)	The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.	Post procedure
Secondary	Percent Diameter Stenosis (%DS)	The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.	8 months post index procedure
Secondary	Acute Gain: In-stent, In-segment	The difference between post- and pre-procedural MLD.	8 months post index procedure
Secondary	Net Gain: In-stent, In-segment	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).	8 months post index procedure
Secondary	Late Loss(LL): In-stent, In-segment, Proximal, and Distal	Late loss is calculated as MLD post procedure - MLD at follow-up.	8 months post index procedure