Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- in-segment late loss
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).
详细描述
A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis.
We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo lesion
- •2.5mm =< Reference diameter =< 4mm
- •Lesion length =< 28mm
- •Type A, B1/B2 lesion
排除标准
- •ST-segment elevation MI
- •Reference diameter < 2.5mm or > 4mm
- •Bifurcation lesion
- •Type C lesion
- •history of AMI or stroke within 1 year F. chronic renal disease (Cr > 2mg/dL)
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
- stent thrombosis(9 month)
- MACE(9 month)
- angiographic and procedure success(9 month)
研究者
Chang-Hwan Yoon
Assistant professor
Seoul National University Bundang Hospital