Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- TLR (Target lesion revascularization)
研究概览
简要总结
The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.
详细描述
Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts, and drug-eluting devices might be beneficial in this field as well.
In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.
The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any venous bypass with stenosis warranting intervention
排除标准
- •Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
结局指标
主要结局
TLR (Target lesion revascularization)
时间窗: 12 months
Any reintervention to the same lesion.
Graft occlusion
时间窗: 0-12 months
Occlusion of the bypass graft
次要结局
- Major amputation(0-12 months)
- Death(0-12 months)
研究者
Maarit Venermo
Professor of Vascular Surgery
Helsinki University Central Hospital