Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Target lesion patency at 6-month follow-up.
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.
详细描述
Peripheral artery disease (PAD) in the lower extremities can cause claudication, pain in the legs or feet and slowly wounds that can affect patients' quality of life and increase the risk of leg amputation and death. Both conventional balloon angioplasty (CBA) alone and CBA plus bare metal stents are the current primary endovascular therapy to treat PAD. However, exaggerated neointimal hyperplasia leading to in-stent restenosis is associated with CBA. Paclitaxel coated balloons have been recognized to be safe and effective for the treatment of coronary in-stent restenosis, which the investigators hypothesize to be applicable in femoropopliteal cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years or older
- •chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5
- •in-stent restenosis or occlusion in SFA or PPA 20mm - 200mm
排除标准
- •participation in another investigational drug or device trial
- •life expectancy less than 12 months
- •acute ischemia and/or acute thrombosis of the SFA/PPA
结局指标
主要结局
Target lesion patency at 6-month follow-up.
时间窗: 6-month post index procedure
Patency of target lesion at 6-month follow-up based on duplex ultrasound.
次要结局
- Clinical success up to 12 months post index procedure(12 months post index procedure)