NCT00331578已完成4 期
Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,077
- 主要终点
- MACE(Major adverse cardiac events)
研究概览
简要总结
The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs used for 6 months after the implantation of degradable drug coating stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who should be full fill the criteria of using Excel stent.
- •Each included patient should allowed to use Excel stent.
- •Complete revascularization can be achieved through one invasive operation.
排除标准
- •Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently.
- •Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition.
- •NYH Cardiac functional grading>3 or Echocardiography LVEF<0.
- •Patient with complete revascularization cannot be resolved by one operation.
结局指标
主要结局
MACE(Major adverse cardiac events)
时间窗: 12 months
次要结局
- MACE(30 days and 6 months)
研究者
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