Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,002
- 试验地点
- 1
- 主要终点
- Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
研究概览
简要总结
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.
This study has no primary outcome measure. All observations are of equal weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years of age at the time of signing the informed consent.
- •The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
- •Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.
排除标准
- •No other exclusion criteria are specified for this study.
结局指标
主要结局
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
时间窗: ≤ 7 days after index procedure (Hospitalization)
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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
次要结局
未报告次要终点