NCT01148329已完成不适用
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,010
- 试验地点
- 40
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
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
- •According to Instructions For Use
排除标准
- •Contraindications according to Instructions for Use
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: One year
Overall and PROMUS™ Element™ stent related TVF rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation.
次要结局
- Death or MI rates(30 days, 6 months, 12 months and then annually through 5 years)
- Cardiac death rates(30 days, 6 months, 12 months and then annually through 5 years)
- All death rates(30 days, 6 months, 12 months and then annually through 5 years)
- TVR rates(30 days, 6 months, 12 months and then annually through 5 years)
- MI Rates(30 days, 6 months, 12 months and then annually through 5 years)
- Non-cardiac death rates(30 days, 6 months, 12 months and then annually through 5 years)
- Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)(30 days, 6 months, 12 months and then annually through 5 years)
- All death or MI rates(30 days, 6 months, 12 months and then annually through 5 years)
研究者
研究点 (40)
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