NCT03089450Unknown不适用
A Multicenter, Subject-blinded, Randomized Study to Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent in Patients Undergoing Drug-eluting Stent Procedure After Coronary Angiography
CGBio Inc.1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2017年3月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- in-segment late loss
研究概览
简要总结
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)
详细描述
A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one lesion with a diameter stenosis >50%
- •suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
- •Gr 1 ≤TIMI flow
排除标准
- •ST-segment elevation MI
- •Bifurcation lesion
- •Chronic total occulusion
- •Restenosis lesion
- •Graft vessel lesion
- •Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year
- •Cardiogenic shock or hemodynamic compromise
- •Existing impairment in liver and kidney.
结局指标
主要结局
in-segment late loss
时间窗: 9 month
angiographic in-segment late loss measure by QCA program
次要结局
- in-stent late loss(9 month)
- MACE(9 month)
- Restenosis rate(9month)
研究者
研究点 (1)
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