Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents". Sierra 75 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 44
- 主要终点
- Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .
研究概览
简要总结
This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.
详细描述
This prospective registry is intended to analyze clinical outcomes in elderly patients treated with XIENCE Sierra stent and in pre-established subgroups (stable and unstable coronary artery disease).
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 75 years.
- •With indication of percutaneous revascularization.
- •Presence of de novo coronary artery lesions located in a native coronary artery.
- •Informed consent signed
排除标准
- •Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention)
- •Cardiac arrest before the PCI
- •Life expectancy of the patient under 1 year
- •Participation in another study with a drug or device in clinical research
- •Clinical decision that excludes the use of drug-eluting stents
- •Confirmed allergy to aspirin and / or thienopyridines.
结局指标
主要结局
Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .
时间窗: 12 month
The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .
Efficacy.The incidence of clinically driven target lesion revascularization (TLR).
时间窗: 12 month
The incidence of clinically driven target lesion revascularization (TLR).
次要结局
- Collection of imaging data by Optical coherence tomography (OCT).(12 month)
- Collection of imaging data by Intravascular Ultrasound (IVUS).(12 month)
- Rate of patients with DAPT.(From 6 to 12 months)
- Target lesion revascularization.(12 month)
- Stent thrombosis (ARC definite/probable).(12 month)
- Major bleeding event (BARC type 2-5).(12 month)
- Stroke.(12 month)
- Procedural success.(12 month)
- All death.(12 month)
- Cardiac death.(12 month)
- Target Vessel revascularization.(12 month)