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

Coronary Artery Disease Clinical Trial

Official title:

XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513719
• Other study ID #: 12-303
• Status: Completed
• Start date: May 13, 2013
• Est. completion date: September 2019

Study information

• Verified date: April 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.

Description:

Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

• Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.
• 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.
• Patients who are treated (stent delivery system inserted into the body) by XIENCE PRIME SV will be registered (including provisional stenting for side branch treatment but excluding bail-out only use).
• The observations will be compiled on a per-patient basis even if multiple stents are implanted during the index procedure.
• A patient whose side-branch is treated by XIENCE PRIME SV can be registered. In such a case, main vessel should be treated by XIENCE PRIME.
• A patient who are treated by other drug eluting stent (DES) for planned stent and XIENCE PRIME SV for bail-out purpose cannot be registered.
• Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.
• A patient who is treated, but failed to be implanted by XIENCE PRIME SV and finally treated by other devices only (No XIENCE PRIME SV are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the PRIME stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE PRIME SV stent is not required.
• A patient may have another lesion(s) that may be treated by larger diameter stent(s). In such a case, treatment by XIENCE PRIME is preferable. Lesion(s) treated by other than XIENCE PRIME is not considered as the target lesion.

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Artery Occlusion
• Coronary Occlusion
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• XIENCE PRIME SV Everolimus Eluting Coronary Stent
Patients receiving XIENCE PRIME SV Everolimus Eluting Stent

Locations

Country	Name	City	State
Japan	Kimitsu Chuo Hospital	Chiba
Japan	Fukuoka Wajiro Hospital	Fukuoka
Japan	Kokura Memorial Hospital	Fukuoka
Japan	Hoshi general hospital	Fukushima
Japan	Tsuchiya General Hospital	Hiroshima
Japan	Hyogo Prefectural Amagasaki Hospital	Hyogo
Japan	Tsukuba Medical Center Hospital	Ibaraki
Japan	Ishikawa Prefectual Central Hospital	Ishikawa
Japan	Shonan Kamakura General Hospital	Kanagawa
Japan	Tokai University Hospital	Kanagawa
Japan	Kumamoto Chuo Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Miyazaki City-Gun Ishikai Hospital	Miyazaki
Japan	Kansai Rosai Hospital	Nagoya
Japan	Nagoya Daini Red Cross Hospital	Nagoya
Japan	Heart disease center Sakakibara hospital	Okayama
Japan	Kurashiki Central Hospital	Okayama
Japan	Osaka police hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Sakurabashi Watanabe Hospital	Osaka
Japan	Tokorozawa Heart Center	Saitama
Japan	Hokkaido Ohno hospital	Sapporo
Japan	JCHO Hokkaido Hospital	Sapporo
Japan	Tokeidai memorial hospital	Sapporo
Japan	Sendai Kousei Hospital	Sendai
Japan	Okamura memorial hospital	Shizuoka
Japan	Tokushima Red Cross Hospital	Tokushima
Japan	Mitsui Memorial Hospital	Tokyo
Japan	Teikyo University Hospoital	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo
Japan	Toranomon hospital	Tokyo
Japan	Saiseikai Yokohama City Tobu Hospital	Yokohama
Japan	Showa University Fujigaoka hospital	Yokohama

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 Stent Thrombosis: Acute	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.; Timing: Acute stent thrombosis: 0 to 24 hours after stent implantation	0-24 hours post stent implantation
Primary	Number of Participants With Stent Thrombosis: Subacute	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual 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: Subacute stent thrombosis : >24 hours to 30 days after stent implantation	>24 hours to 30 days post stent implantation
Primary	Number of Participants With Stent Thrombosis: Late	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual 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: Late stent thrombosis : >30 days to 1 year after stent implantation	30 days to 1 year post stent implantation
Secondary	Number of Participants With Stent Thrombosis: Very Late	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual 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: Very late stent thrombosis : >1 year after stent implantation.	>1 year post stent implantation
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).	Pre-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).	post procedure (on day 0)
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).	8 months
Secondary	Success Rate: Percentage of Devices With Implant Success	The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25mm.; 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).	< or = 1 day
Secondary	Success Rate: Percentage of Lesions With Procedural Success	Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).	< or = 1 day
Secondary	Success Rate: XIENCE PRIME Implant Success by Patient	The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25 mm.; Implant success is assessed as per physicians decision, but means that the stent could be implanted at the intended location.	< or = 1 day
Secondary	Number of Death	Death includes cardiac death, non-cardiac death and non-coronary death.	0 to 8 months
Secondary	Number of Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 1 year
Secondary	Number of Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 2 years
Secondary	Number of Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0-3 years
Secondary	Number of Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0-4 years
Secondary	Number of Death	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0-5 years
Secondary	Number of Participants With Myocardial Infarction	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.	0 to 8 months
Secondary	Number of Participants With Myocardial Infarction	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.	0 to 1 year
Secondary	Number of Participants With Myocardial Infarction	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.	0 to 2 years
Secondary	Number of Participants With Myocardial Infarction	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.	0-3 years
Secondary	Number of Participants With Myocardial Infarction	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.	0-4 years
Secondary	Number of Participants With Myocardial Infarction	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.	0-5 years
Secondary	Number of Participants With Target Lesion Revascularization	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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR	0 to 8 months
Secondary	Number of Participants With Target Lesion Revascularization	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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR	0 to 1 year
Secondary	Number of Participants With Target Lesion Revascularization	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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR	0 to 2 years
Secondary	Number of Participants With Target Lesion Revascularization	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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR	0-3 years
Secondary	Number of Participants With Target Lesion Revascularization	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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR	0-4 years
Secondary	Number of Participants With Target Lesion Revascularization	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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR	0-5 years
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)	0 to 8 months
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)	0 to 1 year
Secondary	Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	The number of patient with Ischemia-driven Target vessel revascularization (TLR or TVR, non-TLR)	0 to 2 years
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)	0-3 years
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)	0-4 years
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)	0-5 years
Secondary	Number of Participants With Non-target Vessel Revascularization (Non-TVR)	Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.	0 to 8 months
Secondary	Number of Participants With Non-target Vessel Revascularization (Non-TVR)	Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.	0 to 1 year
Secondary	Number of Participants With Non-target Vessel Revascularization (Non-TVR)	Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.	0 to 2 years
Secondary	Number of Participants With Non-target Vessel Revascularization (Non-TVR)	Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.	0 to 3 years
Secondary	Number of Participants With Non-target Vessel Revascularization (Non-TVR)	Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.	0 to 4 years
Secondary	Number of Participants With Non-target Vessel Revascularization (Non-TVR)	Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.	0 to 5 years
Secondary	Number of Participants With All Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 8 months
Secondary	Number of Participants With All Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 1 year
Secondary	Number of Participants With All Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 2 years
Secondary	Number of Participants With All Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 3 years
Secondary	Number of Participants With All Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 4 years
Secondary	Number of Participants With All Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 5 years
Secondary	Number of Participants With Hemorrhage	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	0 to 8 months
Secondary	Number of Participants With Hemorrhage	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	0 to 1 year
Secondary	Number of Participants With Hemorrhage	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	0 to 2 years
Secondary	Number of Participants With Hemorrhage	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.	0 to 3 years
Secondary	Number of Participants With Hemorrhage	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.	0 to 4 years
Secondary	Number of Participants With Hemorrhage	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.	0 to 5 years
Secondary	Number of Participants With Target Lesion Failure	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 8 months
Secondary	Number of Participants With Target Lesion Failure	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 1 year
Secondary	Number of Participants With Target Lesion Failure	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 2 years
Secondary	Number of Participants With Target Lesion Failure	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 3 years
Secondary	Number of Participants With Target Lesion Failure	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 4 years
Secondary	Number of Participants With Target Lesion Failure	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 5 years
Secondary	Number of Participants With All Death/All MI/All Revascularization		0 to 8 months
Secondary	Number of Participants With All Death/All MI/All Revascularization		0 to 1 year
Secondary	Number of Participants With All Death/All MI/All Revascularization		0 to 2 years
Secondary	Number of Participants With All Death/All MI/All Revascularization		0 to 3 years
Secondary	Number of Participants With All Death/All MI/All Revascularization		0 to 4 years
Secondary	Number of Participants With All Death/All MI/All Revascularization		0 to 5 years
Secondary	Number of Participants With Target Vessel Failure	Target vessel failure includes cardiac death, MI, ischemia driven TLR, ischemia driven TVR, non TLR and ischemia driven TVR (TLR or TVR, nonTLR).	0 to 8 months
Secondary	Number of Participants With Target Vessel Failure	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).	0 to 1 year
Secondary	Number of Participants With Target Vessel Failure	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).	0 to 2 years
Secondary	Number of Participants With Target Vessel Failure	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).	0 to 3 years
Secondary	Number of Participants With Target Vessel Failure	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).	0 to 4 years
Secondary	Number of Participants With Target Vessel Failure	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).	0 to 5 years
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Clinically indicated target lesion revascularization (CI-TLR).	0 to 8 months
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).	0 to 1 year
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).	0 to 2 years
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).	0 to 3 years
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).	0 to 4 years
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).	0 to 5 years
Secondary	Number of Participants With Death or MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG.; Non-Q wave MI Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 8 months
Secondary	Number of Participants With Death or MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG.; Non-Q wave MI Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1 year
Secondary	Number of Participants With Death or MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 2 years
Secondary	Number of Participants With Death or MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 3 years
Secondary	Number of Participants With Death or MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 4 years
Secondary	Number of Participants With Death or MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 5 years
Secondary	Number of Participants With Cardiac Death or 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.	0 to 8 months
Secondary	Number of Participants With Cardiac Death or 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.	0 to 1 year
Secondary	Number of Participants With Cardiac Death or 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.	0 to 2 years
Secondary	Number of Participants With Cardiac Death or 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.	0 to 3 years
Secondary	Number of Participants With Cardiac Death or 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.	0 to 4 years
Secondary	Number of Participants With Cardiac Death or 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.	0 to 5 years
Secondary	Number of Participants With Cardiac Death or Target-Vessel 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).	0 to 8 months
Secondary	Number of Participants With Cardiac Death or Target Vessel-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).	0 to 1 year
Secondary	Number of Participants With Cardiac Death or Target Vessel 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).	0 to 2 years
Secondary	Number of Participants With Cardiac Death or Target Vessel 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).	0 to 3 years
Secondary	Number of Participants With Cardiac Death or Target Vessel 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).	0 to 4 years
Secondary	Number of Participants With Cardiac Death or Target Vessel 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).	0 to 5 years
Secondary	Acute Gain: In-stent,In-segment	The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD).	Pre procedure to post procedure (on day 0)
Secondary	Late Loss(LL): In-stent,In-segment,Proximal, and Distal	Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].	8 months
Secondary	Net Gain: In-stent, In-segment	Difference between acute gain and late loss.	Post-Procedure (on day 0)