Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- target lesion revascularization
研究概览
简要总结
This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 1-year patency rate of target vessel) in 1 year after the treatment will be compared.
详细描述
Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency after stent implantation. The chronic inflammation induced by stenting could be a main reason of restenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices are developed. Here, the investigators propose the hypothesis that using local drug delivery with TAPAS balloon system can relieve the inflammation induced by the stent implantation and balloon dilation. Therefore, 40 patients of femoropopliteal in-stent restenosis will be randomly allocated into the group "balloon dilation+local drug delivery with balloon system" or "balloon dilation only". The 1-year patency rate,12-month late lumen loss, incidence of complications, imaging parameters will be compared between two groups.
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)
盲法说明
only the doctors know the group the patient goes into
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have signed the informed consent
- •age of 18-80 years old
- •femoropopliteal artery disease (Rutherford 2-4)
- •femoropopliteal in-stent restenosis (≥70%)
- •length of lesion ≤ 20cm
- •at least one infrapopliteal run-off vessel
排除标准
- •serum Cr > 150 umol/L
- •patients with acute thrombosis
- •stent fracture within femoropopliteal artery
- •allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
- •already recruited into other clinical trials that could influence the outcome of this study
- •pregnancy and lactation
- •relatively easy bleeding
- •malignancy or irreversible organ failure
研究组 & 干预措施
balloon dilation only
The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
干预措施: balloon dilation only (Device)
balloon dilation+local drug delivery
The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
干预措施: balloon dilation+local drug delivery (Device)
结局指标
主要结局
target lesion revascularization
时间窗: 12 months
the revascularization rate of target lesion
次要结局
- Rutherford level(12 months)
- ABI(12 months)
- late lumen loss rate at secondary intervention(12 months)
- adverse events(12 months)
- 12-month patency rate(12 months)
- MLD(6 months)
- restenosis rate(6 months)
- 6-month patency rate(6 months)
- main amputation(12 months)