NCT00989066已完成不适用
Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
Cardiovascular Research Center, Brazil24 个研究点 分布在 1 个国家目标入组 535 人开始时间: 2008年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 535
- 试验地点
- 24
- 主要终点
- Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
研究概览
简要总结
To evaluate the performance and long-term clinical outcomes of the Xience V everolimus-eluting coronary stent system (EECSS) in the treatment of minimally selective, high risk patients in the real-world clinical practice.
详细描述
Prospective, multicenter, non-randomized, post-marketing web-based registry.Patients all comers assigned for percutaneous coronary intervention (PCI) who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Xience V EECSS only can be included on this Registry.
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
- •Patients >18 years of age; clinical indication for elective or emergency PCI with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups
- •Diseased coronary vessel(s) with the presence of at least one obstruction >50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with anatomy suitable for percutaneous treatment with implantation of the Xience V EECSS
排除标准
- •Known illness with life expectancy <24 months; impossibility to comply with all protocol follow-ups
- •Coronary anatomy unsuitable for percutaneous treatment with implantation of the Xience V EECSS
结局指标
主要结局
Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
时间窗: 12 months
次要结局
- Rates of procedural success(24 months)
- MACE at in-hospital(30 days, 6 months, and 24 months)
- Toll-like receptor (TLR)(at 6 and 12 months)
- Stent thrombosis up to 24 mo(up to 24 months)
- Dual anti-platelet therapy compliance(at 1, 6 and 12 months)
- Major bleeding events(at 1, 6 and 12 mo)
研究者
研究点 (24)
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