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

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)

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Stent Thrombosis; Coronary Restenosis; Chronic Coronary Occlusion; Vascular Disease; Coronary Artery Stenosis; Angioplasty
• Intervention / Treatment: Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

• Study Type: Observational
• Enrollment (Actual): 2605

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Clara, California, United States, 95054
      • Abbott Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General Chinese interventional cardiology population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 407 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 772 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1137 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1502 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1867 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Stent Thrombosis	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.	0 to 1867 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 407 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 772 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1137 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1502 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1867 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	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.	0 to 407 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	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.	0 to 772 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	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.	0 to 1137 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	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.	0 to 1502 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)	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.	0 to 1867 days
Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 407 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 772 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 1137 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 1502 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 1867 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	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.	0 to 407 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	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.	0 to 772 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	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.	0 to 1137 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	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.	0 to 1502 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))	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.	0 to 1867 days
Number of Participants With Composite Rate of All Death and Any MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG.; Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 407 days
Number of Participants With Composite Rate of All Death and Any MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG.; Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 772 days
Number of Participants With Composite Rate of All Death and Any MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG.; Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1137 days
Number of Participants With Composite Rate of All Death and Any MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG.; Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1502 days
Number of Participants With Composite Rate of All Death and Any MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG.; Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1867 days
Number of Participants Experiencing 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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	0 to 407 days
Number of Participants Experiencing 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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	0 to 772 days
Number of Participants Experiencing 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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	0 to 1137 days
Number of Participants Experiencing 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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	0 to 1502 days
Number of Participants Experiencing 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). - Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	0 to 1867 days
Number of Participants With Any MI	Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 407 days
Number of Participants With Any MI	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 772 days
Number of Participants With Any MI	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1137 days
Number of Participants With Any MI	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1502 days
Number of Participants With Any MI	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1867 days
Number of Participants With Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 407 days
Number of Participants With Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 772 days
Number of Participants With Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 1137 days
Number of Participants With Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.; Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.; Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 1502 days
Number of Participants With Revascularization	Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.	0 to 1867 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events: Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention.; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise.; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.	0 to 407 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events: Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding	0 to 772 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events: Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding	0 to 1137 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events: Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding	0 to 1502 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events: Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding	0 to 1867 days
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.	1 year
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.	2 years
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.	3 years
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.	4 years
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)	Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.	5 years
Number of Participants With All Target Lesions 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.	0 to 407 days
Number of Participants With All Target Lesion 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.	0 to 772 days
Number of Participants With All Target Lesions 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.	0 to 1137 days
Number of Participants With All Target Lesion 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.	0 to 1502 days
Number of Participants With All Target Lesion 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.	0 to 1867 days
Number of Participants With All Target Vessel Revascularization	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.	0 to 407 days
Number of Participants With All Target Vessel Revascularization	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.	0 to 772 days
Number of Participants With All Target Vessel Revascularization	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.	0 to 1137 days
Number of Participants With All Target Vessel Revascularization	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.	0 to 1502 days
Number of Participants With All Target Vessel Revascularization	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.	0 to 1867 days

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 24, 2010
• First Submitted That Met QC Criteria: November 26, 2010
• First Posted (Estimate): November 29, 2010

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: China; Stents; Drug eluting stents; DES; XIENCE V EECSS
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Ischemia; Thrombosis; Coronary Occlusion; Coronary Stenosis; Coronary Restenosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 10-388