Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder - Trial)
试验速览
- 阶段
- 2 期
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Late lumen loss of vessel segment following dilatation after 6 months
研究概览
简要总结
The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.
详细描述
Drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries. Unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery. We could show that a non-stent based delivery of Taxan was equal or superior to drug eluting stents in an animal model. This was both true for the coronary arteries and peripheral vessels.
In a prospective blinded trail >135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty, or together with contrast media. One group serves as control. There were no limitations due to lesion length. Follow-up angiography will be after 6 months, 12 months and 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis > 2cm in the arteria femoralis superficialis or arteria poplitea
- •Various criteria assuring ethical issues and follow up
排除标准
- •Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
- •Pregnancy can not be excluded
- •Doubts in the willingness or capability of the patient to allow 6 months follow up
结局指标
主要结局
Late lumen loss of vessel segment following dilatation after 6 months
次要结局
- Thrombotic complications or revascularization of the target vessel, death; adverse reactions known to occur after paclitaxel (high dose tumor therapy except reactions to the detergent)
- Paclitaxel plasma concentration will be determined immediately after administration