A Multicenter Postmarket Surveillance Registry Evaluating the Performance and Long Term Safety of the Presillion Stent in de Novo Native Coronary Artery Lesions. Iberian Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 试验地点
- 13
- 主要终点
- Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))
研究概览
简要总结
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
详细描述
Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up.
Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions
Study design: multicenter, prospective, observational
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
- •All subjects treated with Presillion stent up to two de novo coronary artery lesions
排除标准
- •No specified
结局指标
主要结局
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))
时间窗: at 12 months follow-up
Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR). The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).
次要结局
- Stroke(Up to 12 months)
- Lesion Success(Peri-procedure up to discharge)
- Clinically Driven TLR(up to 12 months)
- Target Vessel Failure(Up to 12 months)
- Major Bleeding(Up to 12 months)
- Device Success(Peri-procedure up to discharge)
- Clinically Driven TVR(Up to 12 months)
- Stent Thrombosis(Up to 12 months)
- Procedural Success(Peri-procedure up to discharge)
- Myocardial Infarction(Up to 12 months)