CTRI/2008/091/000213已完成4 期
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) India Post-Marketing Registry
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 18
- 主要终点
- Stent thrombosis rates as defined by Academic Research Consortium (ARC)
研究概览
简要总结
XIENCE V India is a prospective, open-label, multi-center, observational, single-arm registry to evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
入选标准
- •The patient agrees to participate in this study by signing the EC approved informed consent form.
- •Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.
排除标准
- •The inability to obtain an informed consent is an exclusion criterion.
结局指标
主要结局
Stent thrombosis rates as defined by Academic Research Consortium (ARC)
时间窗: Annually through to 5 years
次要结局
- Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG)(30, 180 days and at 1, 2, 3, 4 and 5 years)
- Composite rate of cardiac death and any MI (Q-wave and non Q-wave)(30, 180 days and at 2, 3, 4 and 5 years)
- Composite rate of all death and any MI (Q-wave and non Q-wave)(30, 180 days and at 1, 2, 3, 4 and 5 years)
- Death (cardiac death, vascular death, and non-cardiovascular death)(30, 180 days and at 1, 2, 3, 4 and 5 years)
- Any MI (Q-wave and non Q-wave)(30, 180 days and at 1, 2, 3, 4 and 5 years)
- Compliance and therapy interruptions with prescribed adjunctive anti-platelet therapy(14, 30, 180 days and at 1, 2, 3, 4 and 5 years)
- Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)(30, 180 days and at 1, 2, 3, 4 and 5 years)
- Clinical device and procedural success(Acute)
- Major bleeding complications(14, 30, 180 days and at 1, 2, 3, 4 and 5 years)
- Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire(at baseline, 180 days, and 1 year.)
- Stent thrombosis(24 hours (acute) and 30 days (sub-acute))
- Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)(30, 180 days and 1, 2, 3, 4, and 5 years)
研究者
研究点 (18)
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