XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,605
- 试验地点
- 1
- 主要终点
- Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
研究概览
简要总结
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •The inability to obtain a signed ICF
结局指标
主要结局
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
时间窗: 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.
次要结局
- Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)(0 to 1867 days)
- Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization(0 to 1867 days)
- Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)(0 to 407 days)
- Number of Participants With Major Bleeding Complications (According to GUSTO Classification)(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))(0 to 1867 days)
- Number of Participants Experiencing Death(0 to 1867 days)
- Number of Participants With Revascularization(0 to 1867 days)
- Number of Participants With All Target Lesions Revascularization(0 to 1137 days)
- Number of Participants With All Target Vessel Revascularization(0 to 1867 days)
- Number of Participants With Stent Thrombosis(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)(0 to 1867 days)
- Number of Participants With Any MI(0 to 1867 days)
- Number of Participants With Composite Rate of All Death and Any MI(0 to 1867 days)
- Number of Participants With All Target Lesion Revascularization(0 to 1867 days)
- Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)(5 years)