Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,059
- 试验地点
- 1
- 主要终点
- 12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)
研究概览
简要总结
To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.
详细描述
Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or clinic visit
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject must be at least 18 years of age
- •Subject understands and provides written informed consent
- •Subject who is clinically indicated and will have an attempt of at least one Promus PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least one Promus PREMIERTM Stent
- •Subject is willing to comply with all protocol-required follow-up evaluation
排除标准
- •Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an "all comers" study.
结局指标
主要结局
12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)
时间窗: 12-month follow up
The primary endpoint is the 12-month major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)
12-month Major Adverse Cardiac Event (MACE) Rate
时间窗: 12 months
12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR).
次要结局
- 12-month Cardiac Death(12 months)
- 12-month Myocardial Infarction(12 months)
- 12-month TVR(12 months)