YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.
详细描述
Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5
- •De-novo stenosis of > 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery
- •Target lesion length of ≤ 45 mm
排除标准
- •Coagulation disorder
- •Known allergy to contrast medium
- •Contraindications to antiplatelet therapy or heparin
结局指标
主要结局
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
时间窗: 12 months
次要结局
- Number of reinterventions of target vessel(12 months)
研究者
Prof. Dr. med. Thomas Zeller
Prof.
Herz-Zentrums Bad Krozingen