Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Late loss
研究概览
简要总结
Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. The Genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients >18 years old
- •lesion in native coronary artery
- •de-novo stenosis
- •indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic FFR)
- •range of reference diameter 2.5 to 4.0mm
排除标准
- •lesion in saphenous vein graft
- •chronic total occlusion
- •bifurcation lesion requiring stenting of main and side branch
- •left main stenosis
- •restenosis
- •in-Stent restenosis
- •contraindication for dual antiplatelet therapy for the following 6 months
- •coronary aneurysm in target vessel
结局指标
主要结局
Late loss
时间窗: 6 months
次要结局
- Binary restenosis rate(6 month)
- Diameter stenosis(6 months)
- Stent thrombosis(2, 6, 12, 24, 36, 48, 60 months)
- Late loss index(6 months)
- Target vessel revascularization(2, 6, 12, 24, 36, 48, 60 months)
- Target lesion revascularization(2, 6, 12, 24, 36, 48, 60 months)
- Major adverse cardiac events(2, 6, 12, 24, 36, 48, 60 months)
研究者
Jochen Wohrle
Prof. Dr. Jochen Wöhrle
University of Ulm