NCT01056120已完成不适用
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 1,026
- 试验地点
- 50
- 主要终点
- MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)
研究概览
简要总结
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.
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
- •Patient signed informed consent for data release
- •Patient eligible for percutaneous coronary intervention (PCI)
- •De novo and re-stenosed coronary artery lesions
- •Patient is geographically stable and willing to participate at all follow up assessments
- •Patient is > 18 years of age
排除标准
- •Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
- •Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
- •Patient presents with ISR (in-stent restenosis)
结局指标
主要结局
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)
时间窗: 6 months
次要结局
- • MACE after 12 and 24 months • TVR after 6, 12 and 24 months • Stent Thrombosis at 6, 12 and 24 months acc. to the academic research consortium -ARC (13)(6,12, 24 Months)
研究者
研究点 (50)
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