XV CHINA SAS: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01249027

Collaborator

(none)

2,605

Enrollment

Location

Duration (Months)

35.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:

Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
Evaluate patient compliance to dual antiplatelet therapy (DAPT)

Condition or Disease	Intervention/Treatment	Phase
Angioplasty Chronic Coronary Occlusion Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis	Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Study Design

Study Type:

Observational

Actual Enrollment :

2605 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Observational Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).	Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.

Arm

Intervention/Treatment

Observational

Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).

Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.

Outcome Measures

Primary Outcome Measures

Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) [0 to 407 days]
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) [0 to 772 days]
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) [0 to 1137 days]
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) [0 to 1502 days]
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) [0 to 1867 days]
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.

Secondary Outcome Measures

Number of Participants With Stent Thrombosis [0 to 1867 days]
Definite Stent Thrombosis (ST) occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Nonocclusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization [0 to 407 days]
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.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization [0 to 772 days]
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.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization [0 to 1137 days]
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.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization [0 to 1502 days]
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.
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization [0 to 1867 days]
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.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) [0 to 407 days]
Cardiac Death: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). 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.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) [0 to 772 days]
Cardiac Death: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). 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.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) [0 to 1137 days]
Cardiac Death: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). 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.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) [0 to 1502 days]
Cardiac Death: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). 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.
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) [0 to 1867 days]
Cardiac Death: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). 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.
Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) [0 to 407 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) [0 to 772 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) [0 to 1137 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) [0 to 1502 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) [0 to 1867 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) [0 to 407 days]
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) [0 to 772 days]
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) [0 to 1137 days]
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) [0 to 1502 days]
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) [0 to 1867 days]
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Composite Rate of All Death and Any MI [0 to 407 days]
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.
Number of Participants With Composite Rate of All Death and Any MI [0 to 772 days]
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.
Number of Participants With Composite Rate of All Death and Any MI [0 to 1137 days]
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.
Number of Participants With Composite Rate of All Death and Any MI [0 to 1502 days]
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.
Number of Participants With Composite Rate of All Death and Any MI [0 to 1867 days]
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.
Number of Participants Experiencing Death [0 to 407 days]
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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death [0 to 772 days]
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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death [0 to 1137 days]
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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death [0 to 1502 days]
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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death [0 to 1867 days]
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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants With Any MI [0 to 407 days]
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.
Number of Participants With Any MI [0 to 772 days]
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.
Number of Participants With Any MI [0 to 1137 days]
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.
Number of Participants With Any MI [0 to 1502 days]
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.
Number of Participants With Any MI [0 to 1867 days]
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.
Number of Participants With Revascularization [0 to 407 days]
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.
Number of Participants With Revascularization [0 to 772 days]
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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Number of Participants With Revascularization [0 to 1137 days]
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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Number of Participants With Revascularization [0 to 1502 days]
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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Number of Participants With Revascularization [0 to 1867 days]
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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Number of Participants With Major Bleeding Complications (According to GUSTO Classification) [0 to 407 days]
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.
Number of Participants With Major Bleeding Complications (According to GUSTO Classification) [0 to 772 days]
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
Number of Participants With Major Bleeding Complications (According to GUSTO Classification) [0 to 1137 days]
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
Number of Participants With Major Bleeding Complications (According to GUSTO Classification) [0 to 1502 days]
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
Number of Participants With Major Bleeding Complications (According to GUSTO Classification) [0 to 1867 days]
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
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) [1 year]
Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) [2 years]
Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) [3 years]
Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) [4 years]
Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) [5 years]
Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Number of Participants With All Target Lesions Revascularization [0 to 407 days]
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.
Number of Participants With All Target Lesion Revascularization [0 to 772 days]
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.
Number of Participants With All Target Lesions Revascularization [0 to 1137 days]
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.
Number of Participants With All Target Lesion Revascularization [0 to 1502 days]
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.
Number of Participants With All Target Lesion Revascularization [0 to 1867 days]
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.
Number of Participants With All Target Vessel Revascularization [0 to 407 days]
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.
Number of Participants With All Target Vessel Revascularization [0 to 772 days]
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.
Number of Participants With All Target Vessel Revascularization [0 to 1137 days]
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.
Number of Participants With All Target Vessel Revascularization [0 to 1502 days]
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.
Number of Participants With All Target Vessel Revascularization [0 to 1867 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.

Exclusion Criteria:

The inability to obtain a signed ICF

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Vascular	Santa Clara	California	United States	95054

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Principal Investigator: Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI, Fudan University
Principal Investigator: Jiyan Chen, MD, Institute of Cardiovascular Guangdong, Guangdong Provincial People's Hospital
Principal Investigator: YuJie Zhou, MD, Ph.D, An Zhen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT01249027

Other Study ID Numbers:

10-388

First Posted:

Nov 29, 2010

Last Update Posted:

Mar 1, 2019

Last Verified:

Oct 1, 2018

Keywords provided by Abbott Medical Devices

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	XIENCE V China SAS was designed to enroll approximately 2500 patients. The first patient was enrolled on November 26, 2010. The enrollment was completed on December 10, 2011, with a total of 2605 patients enrolled at 53 sites. Of 2605 patients, a total of 123 subjects were withdrawn. Per protocol population is 2482.
Pre-assignment Detail	A total of 123 subjects were withdrawn due to following reasons: 82 subjects had incomplete informed consent procedures;11 subjects enrolled repeatedly;1 subject did not have a stent at the starting point for surgery;18 subjects surgically implanted with other stents at the start;1 subject withdrew informed consent;10 subjects deregistered.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Period Title: 1 Year Clinical Follow up
STARTED	2482
COMPLETED	2391
NOT COMPLETED	91
Period Title: 1 Year Clinical Follow up
STARTED	2391
COMPLETED	2254
NOT COMPLETED	137
Period Title: 1 Year Clinical Follow up
STARTED	2254
COMPLETED	2223
NOT COMPLETED	31
Period Title: 1 Year Clinical Follow up
STARTED	2223
COMPLETED	2210
NOT COMPLETED	13
Period Title: 1 Year Clinical Follow up
STARTED	2210
COMPLETED	2142
NOT COMPLETED	68

Baseline Characteristics

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Overall Participants	2482
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1586 63.9%
>=65 years	896 36.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.69 (11.13)
Sex: Female, Male (Count of Participants)
Female	626 25.2%
Male	1856 74.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Description	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	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	33 1.3%

2. Primary Outcome

Title	Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Description	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	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	55 2.2%

3. Primary Outcome

Title	Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Description	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	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	63 2.5%

4. Primary Outcome

Title	Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Description	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	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	76 3.1%

5. Primary Outcome

Title	Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Description	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	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	84 3.4%

6. Secondary Outcome

Title	Number of Participants With Stent Thrombosis
Description	Definite Stent Thrombosis (ST) occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Nonocclusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-followup, defined as subjects who are lost to followup through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Definite	5 0.2%
Definite & Probable	10 0.4%

7. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	90 3.6%

8. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	154 6.2%

9. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	191 7.7%

10. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	235 9.5%

11. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	271 10.9%

12. Secondary Outcome

Title	Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Description	Cardiac Death: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). 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	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	35 1.4%

13. Secondary Outcome

Title	Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Description	Cardiac Death: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). 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	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	62 2.5%

14. Secondary Outcome

Title	Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Description	Cardiac Death: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). 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	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	71 2.9%

15. Secondary Outcome

Title	Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Description	Cardiac Death: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). 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	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	87 3.5%

16. Secondary Outcome

Title	Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Description	Cardiac Death: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). 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	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	95 3.8%

17. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Description	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	35 1.4%

18. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Description	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	60 2.4%

19. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Description	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	69 2.8%

20. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Description	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	85 3.4%

21. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Description	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	93 3.7%

22. Secondary Outcome

Title	Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Description	Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	50 2%

23. Secondary Outcome

Title	Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Description	Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	86 3.5%

24. Secondary Outcome

Title	Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Description	Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	100 4%

25. Secondary Outcome

Title	Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Description	Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	123 5%

26. Secondary Outcome

Title	Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Description	Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	136 5.5%

27. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death and Any MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	46 1.9%

28. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death and Any MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	80 3.2%

29. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death and Any MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	92 3.7%

30. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death and Any MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	120 4.8%

31. Secondary Outcome

Title	Number of Participants With Composite Rate of All Death and Any MI
Description	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	137 5.5%

32. Secondary Outcome

Title	Number of Participants Experiencing Death
Description	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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	34 1.4%

33. Secondary Outcome

Title	Number of Participants Experiencing Death
Description	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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	64 2.6%

34. Secondary Outcome

Title	Number of Participants Experiencing Death
Description	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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	75 3%

35. Secondary Outcome

Title	Number of Participants Experiencing Death
Description	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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	98 3.9%

36. Secondary Outcome

Title	Number of Participants Experiencing Death
Description	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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	113 4.6%

37. Secondary Outcome

Title	Number of Participants With Any MI
Description	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	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	13 0.5%

38. Secondary Outcome

Title	Number of Participants With Any MI
Description	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	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	20 0.8%

39. Secondary Outcome

Title	Number of Participants With Any MI
Description	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	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	23 0.9%

40. Secondary Outcome

Title	Number of Participants With Any MI
Description	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	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	28 1.1%

41. Secondary Outcome

Title	Number of Participants With Any MI
Description	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	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	31 1.2%

42. Secondary Outcome

Title	Number of Participants With Revascularization
Description	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	49 2%

43. Secondary Outcome

Title	Number of Participants With Revascularization
Description	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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	83 3.3%

44. Secondary Outcome

Title	Number of Participants With Revascularization
Description	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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	111 4.5%

45. Secondary Outcome

Title	Number of Participants With Revascularization
Description	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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	132 5.3%

46. Secondary Outcome

Title	Number of Participants With Revascularization
Description	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 Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	154 6.2%

47. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
Description	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	0 to 407 days

Outcome Measure Data

Analysis Population Description
Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2388
Count of Participants [Participants]	14 0.6%

48. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
Description	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	0 to 772 days

Outcome Measure Data

Analysis Population Description
Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2231
Count of Participants [Participants]	18 0.7%

49. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
Description	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	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2160
Count of Participants [Participants]	26 1%

50. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
Description	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	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2126
Count of Participants [Participants]	31 1.2%

51. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
Description	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	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2029
Count of Participants [Participants]	18 0.7%

52. Secondary Outcome

Title	Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Description	Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2384
Count of Participants [Participants]	2231 89.9%

53. Secondary Outcome

Title	Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Description	Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description
Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2225
Count of Participants [Participants]	1085 43.7%

54. Secondary Outcome

Title	Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Description	Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description
Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2151
Count of Participants [Participants]	934 37.6%

55. Secondary Outcome

Title	Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Description	Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description
Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2116
Count of Participants [Participants]	879 35.4%

56. Secondary Outcome

Title	Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Description	Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description
Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2029
Count of Participants [Participants]	800 32.2%

57. Secondary Outcome

Title	Number of Participants With All Target Lesions Revascularization
Description	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.
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	12 0.5%

58. Secondary Outcome

Title	Number of Participants With All Target Lesion Revascularization
Description	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.
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	21 0.8%

59. Secondary Outcome

Title	Number of Participants With All Target Lesions Revascularization
Description	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.
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	25 1%

60. Secondary Outcome

Title	Number of Participants With All Target Lesion Revascularization
Description	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.
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	30 1.2%

61. Secondary Outcome

Title	Number of Participants With All Target Lesion Revascularization
Description	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.
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	33 1.3%

62. Secondary Outcome

Title	Number of Participants With All Target Vessel Revascularization
Description	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.
Time Frame	0 to 407 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2391
Count of Participants [Participants]	20 0.8%

63. Secondary Outcome

Title	Number of Participants With All Target Vessel Revascularization
Description	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.
Time Frame	0 to 772 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2254
Count of Participants [Participants]	36 1.5%

64. Secondary Outcome

Title	Number of Participants With All Target Vessel Revascularization
Description	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.
Time Frame	0 to 1137 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2223
Count of Participants [Participants]	42 1.7%

65. Secondary Outcome

Title	Number of Participants With All Target Vessel Revascularization
Description	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.
Time Frame	0 to 1502 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2210
Count of Participants [Participants]	53 2.1%

66. Secondary Outcome

Title	Number of Participants With All Target Vessel Revascularization
Description	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.
Time Frame	0 to 1867 days

Outcome Measure Data

Analysis Population Description
Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Measure Participants	2142
Count of Participants [Participants]	60 2.4%

Adverse Events

	Observational
Time Frame	5 years
Adverse Event Reporting Description	Safety data was assessed based on the per protocol population (2482).

Arm/Group Title	Observational
Arm/Group Description	Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). XIENCE V® Everolimus Eluting Coronary Stent System (EECSS): Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	113/2482 (4.6%)
Serious Adverse Events
	Observational
	Affected / at Risk (%)	# Events
Total	574/2482 (23.1%)
Cardiac disorders
Acute Heart Failure	2/2482 (0.1%)
Acute Left Heart Failure	1/2482 (0%)
Acute Left Ventricular Failure	1/2482 (0%)
Acute Myocardial Infarction (AMI)	4/2482 (0.2%)
Acute coronary syndrome (ACS)	3/2482 (0.1%)
Acute coronary syndrome and heart failure	1/2482 (0%)
Adams-Stokes Syndrome (Ventricular fibrillation (VF))	1/2482 (0%)
Angina	121/2482 (4.9%)
Angina and Coronary Heart Disease	3/2482 (0.1%)
Arrhythmia	8/2482 (0.3%)
Atrial Fibrillation and Tachycardia	1/2482 (0%)
Atrial fibrillation	1/2482 (0%)
Atrioventricular (AV) Block	1/2482 (0%)
Bradycardia	1/2482 (0%)
Cardiac Arrest	3/2482 (0.1%)
Cardiac Function Insufficiency	4/2482 (0.2%)
Cardiac Rupture	1/2482 (0%)
Cardiac death	2/2482 (0.1%)
Cardiogenic shock	1/2482 (0%)
Cardiopulmonary disease	1/2482 (0%)
Coronary Artery Disease recurrence	5/2482 (0.2%)
Coronary Atherosclerotic Heart Disease	3/2482 (0.1%)
Coronary Heart Disease	56/2482 (2.3%)
Coronary artery disease	8/2482 (0.3%)
Coronary artery revascularization	2/2482 (0.1%)
Coronary heart disease worsened	2/2482 (0.1%)
Heart Disease	1/2482 (0%)
Heart Failure	24/2482 (1%)
Ischemic cardiomyopathy	1/2482 (0%)
Labor angina	1/2482 (0%)
Left anterior descending (LAD) proximal stent occlusion	1/2482 (0%)
Myocardial Infarction	21/2482 (0.8%)
Non-ST segment elevation myocardial infarction (NSTEMI)	6/2482 (0.2%)
Old Myocardial Infarction	2/2482 (0.1%)
Palpitation	7/2482 (0.3%)
Palpitation and Atrial fibrillation	1/2482 (0%)
Paroxysmal Atrial Fibrillation	2/2482 (0.1%)
Proximal right coronary artery (RCA) stenosis, not within the stent	1/2482 (0%)
Sequelae of cerebral infarction	1/2482 (0%)
Stable Angina	11/2482 (0.4%)
Unstable Angina	119/2482 (4.8%)
Ventricular Tachycardia	1/2482 (0%)
Ventricular extrasystole	1/2482 (0%)
Coronary Artery Stenosis	1/2482 (0%)
Heart surgery	1/2482 (0%)
Ear and labyrinth disorders
Deaf	1/2482 (0%)
Endocrine disorders
Brain dysfunction	1/2482 (0%)
Gastrointestinal disorders
Acute Gastroenteritis	2/2482 (0.1%)
Acute Intestinal Obstruction	1/2482 (0%)
Appendicitis	1/2482 (0%)
Biliary colic	1/2482 (0%)
Duodenal ulcer	1/2482 (0%)
Gallstone	1/2482 (0%)
Gastritis	1/2482 (0%)
Gastroenteritis	1/2482 (0%)
Gastrointestinal Bleeding	5/2482 (0.2%)
Incomplete intestinal obstruction	1/2482 (0%)
Intestinal obstruction	1/2482 (0%)
Upper Gastrointestinal Bleeding	6/2482 (0.2%)
General disorders
Abdominal Pain	1/2482 (0%)
Atypical chest pain	1/2482 (0%)
Bleeding Gums	1/2482 (0%)
Chest Discomfort	1/2482 (0%)
Chest Pain	29/2482 (1.2%)
Chest Tightness	25/2482 (1%)
Chest pain and chest tightness	1/2482 (0%)
Colon Occupy	1/2482 (0%)
Complex Ulcer Bleeding	1/2482 (0%)
Death	51/2482 (2.1%)
Hospitalization	2/2482 (0.1%)
Hypovolemic Shock	1/2482 (0%)
Intermittent Hemoptysis and Generalized Pain	1/2482 (0%)
Intracranial Bleeding	1/2482 (0%)
Low Back Pain	1/2482 (0%)
Multiple Organ Failure	4/2482 (0.2%)
Precordial discomfort	1/2482 (0%)
Precordial pain	1/2482 (0%)
Rehospitalization	1/2482 (0%)
Severe bleeding complications	1/2482 (0%)
Shortness of breath and Chest tightness	1/2482 (0%)
Sick Sinus Syndrome	2/2482 (0.1%)
Stomach bleeding	7/2482 (0.3%)
Hernia	1/2482 (0%)
Hepatobiliary disorders
Cholecystitis	1/2482 (0%)
GallStone And Cholecystitis	1/2482 (0%)
Infections and infestations
Common Cold	1/2482 (0%)
Otter disease	1/2482 (0%)
Upper Respiratory Tract Infection	2/2482 (0.1%)
Injury, poisoning and procedural complications
Artery embolization	1/2482 (0%)
Bone fracture	1/2482 (0%)
Cerebral Hemorrhage	12/2482 (0.5%)
Coronary artery revascularization and Coronary artery bypass grafting	1/2482 (0%)
Distal Stent Restenosis	1/2482 (0%)
Multiple rib fractures	1/2482 (0%)
Muscle strain	1/2482 (0%)
Non-Target Vessel Revascularization	3/2482 (0.1%)
Percutaneous Coronary Intervention (PCI)	2/2482 (0.1%)
Post-operative Percutaneous Coronary Intervention (PCI)	5/2482 (0.2%)
Receiving catheter radiofrequency ablation	1/2482 (0%)
Revascularization	2/2482 (0.1%)
Subarachnoid Hemorrhage	2/2482 (0.1%)
Subdural Hematoma	1/2482 (0%)
Metabolism and nutrition disorders
Diabetes	4/2482 (0.2%)
Newly Discovered Diabetes Mellitus	1/2482 (0%)
Type II Diabetes	3/2482 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Advanced Gastric Cancer	1/2482 (0%)
Bladder Cancer	1/2482 (0%)
Duodenal Cancer	1/2482 (0%)
Esophageal Cancer	1/2482 (0%)
Gastric Cancer	2/2482 (0.1%)
Hepatocellular Carcinoma	1/2482 (0%)
Intestinal Cancer	1/2482 (0%)
Kidney tumor metastasis	1/2482 (0%)
Leukemia	1/2482 (0%)
Liver Cancer	6/2482 (0.2%)
Lung Cancer	8/2482 (0.3%)
Lymphoma	1/2482 (0%)
Malignant Liver Tumors	1/2482 (0%)
Prostate Cancer	1/2482 (0%)
Right groin tumor	1/2482 (0%)
Stomach lymphoma	1/2482 (0%)
Throat Malignant Tumor	1/2482 (0%)
Nervous system disorders
Cerebral Infarction	16/2482 (0.6%)
Cerebral Insufficiency	1/2482 (0%)
Cerebral Thrombosis	1/2482 (0%)
Convulsions	1/2482 (0%)
Dizziness	2/2482 (0.1%)
Ischemic stroke	1/2482 (0%)
Peripheral Neuropathy	1/2482 (0%)
Syncope	1/2482 (0%)
Renal and urinary disorders
Acute pyelonephritis	1/2482 (0%)
Kidney stones	1/2482 (0%)
Prostate hyperplasia and urinary incontinence	1/2482 (0%)
Renal Insufficiency	1/2482 (0%)
Reproductive system and breast disorders
Prostatitis	1/2482 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	1/2482 (0%)
Lung Infection	4/2482 (0.2%)
Pneumonia	4/2482 (0.2%)
Respiratory Failure	2/2482 (0.1%)
Skin and subcutaneous tissue disorders
Subcutaneous Bleeding	1/2482 (0%)
Surgical and medical procedures
All Coronary Revascularizations	1/2482 (0%)
Coronary Stent Restenosis	1/2482 (0%)
Vascular disorders
Stent thrombosis	2/2482 (0.1%)
Restenosis	5/2482 (0.2%)
Stenosis	1/2482 (0%)
Stent Stenosis	1/2482 (0%)
Stent restenosis	2/2482 (0.1%)
Upper Extremity Artery Stenosis	1/2482 (0%)
Blood pressure instability	1/2482 (0%)
Carotid Stenosis	1/2482 (0%)
Hypertension	2/2482 (0.1%)
Hypertension deterioration	1/2482 (0%)
Other (Not Including Serious) Adverse Events
	Observational
	Affected / at Risk (%)	# Events
Total	113/2482 (4.6%)
Cardiac disorders
Angina	11/2482 (0.4%)
Arrhythmia	1/2482 (0%)
Atrial Fibrillation	2/2482 (0.1%)
Congestive Heart Failure	1/2482 (0%)
Heart Failure	1/2482 (0%)
Ischemic cardiomyopathy	1/2482 (0%)
Labor angina	2/2482 (0.1%)
Myocardial Infarction	1/2482 (0%)
Myocardial hypertrophy	1/2482 (0%)
Severe palpitation	1/2482 (0%)
Sinus Bradycardia	1/2482 (0%)
Stable angina	3/2482 (0.1%)
Unstable Angina	4/2482 (0.2%)
Eye disorders
Eye Bleeding	1/2482 (0%)
Ocular hyperemia	1/2482 (0%)
Gastrointestinal disorders
Gastric Ulcer	2/2482 (0.1%)
Gastrointestinal Bleeding	3/2482 (0.1%)
Gastrointestinal discomfort	1/2482 (0%)
Stomach Bleeding	4/2482 (0.2%)
Upper Gastrointestinal Bleeding	2/2482 (0.1%)
Upper abdominal discomfort	1/2482 (0%)
Upper gastrointestinal bleeding	3/2482 (0.1%)
General disorders
Bleeding	5/2482 (0.2%)
Bleeding gums	9/2482 (0.4%)
Blood in the stool	2/2482 (0.1%)
Chest Pain	6/2482 (0.2%)
Chest Tightness	7/2482 (0.3%)
Chest Tightness and Chest Pain	1/2482 (0%)
Hemoptysis	1/2482 (0%)
Intermittent chest tightness	1/2482 (0%)
Nose bleeding	2/2482 (0.1%)
Occult blood	1/2482 (0%)
Stomach discomfort	1/2482 (0%)
Stomach pain	2/2482 (0.1%)
Throat bleeding	1/2482 (0%)
Hepatobiliary disorders
Abnormal liver enzymes	1/2482 (0%)
Injury, poisoning and procedural complications
Fundus Hemorrhage	3/2482 (0.1%)
Hand injury	1/2482 (0%)
Hemorrhoids	1/2482 (0%)
Left Subconjunctival Hemorrhage	1/2482 (0%)
Side effects of Aspirin	1/2482 (0%)
Subcutaneous Bleeding	1/2482 (0%)
Investigations
Cardiac Troponin I (Ctni) Increased	3/2482 (0.1%)
Increased myocardial enzymes	2/2482 (0.1%)
Positive occult blood test	1/2482 (0%)
Postoperative Cardiac Troponin I (Ctni) Increased	1/2482 (0%)
Postoperative Troponin I (TnI) Increased	3/2482 (0.1%)
Metabolism and nutrition disorders
Diabetes	1/2482 (0%)
Hyperthyroidism	1/2482 (0%)
Musculoskeletal and connective tissue disorders
Myositis	1/2482 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right lung adenocarcinoma	1/2482 (0%)
Nervous system disorders
Severe dizziness	1/2482 (0%)
Cerebral Infarction	1/2482 (0%)
Dizziness	1/2482 (0%)
Respiratory, thoracic and mediastinal disorders
Shortness of breath	2/2482 (0.1%)
Skin and subcutaneous tissue disorders
Dermatitis	1/2482 (0%)
Skin Bruises	3/2482 (0.1%)
Skin ecchymosis	1/2482 (0%)
Vascular disorders
Hypertension	1/2482 (0%)
Hypotension	1/2482 (0%)
Right Femoral Vein Thrombosis	1/2482 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Leong Roy
Organization	Abbott Vascular
Phone	8133 7475 ext +65
Email	roy.leong@abbott.com

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT01249027

Other Study ID Numbers:

10-388

First Posted:

Nov 29, 2010

Last Update Posted:

Mar 1, 2019

Last Verified:

Oct 1, 2018