LDD in Treatment of Femoropopliteal ISR
- Conditions
- Peripheral Artery DiseaseIn-stent Restenosis
- Interventions
- Device: balloon dilation onlyDevice: balloon dilation+local drug delivery
- Registration Number
- NCT03521843
- Lead Sponsor
- RenJi Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description balloon dilation only balloon dilation only The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis. balloon dilation+local drug delivery balloon dilation+local drug delivery The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
- Primary Outcome Measures
Name Time Method target lesion revascularization 12 months the revascularization rate of target lesion
- Secondary Outcome Measures
Name Time Method adverse events 12 months incidence of treatment related adverse events
late lumen loss rate at secondary intervention 12 months the rate of late lumen loss of target vessel at secondary intervention within 12 months
Rutherford level 12 months change of Rutherford level
ABI 12 months change of ankle brachial index
12-month patency rate 12 months the 12-month patency rate of target vessel
MLD 6 months minimal lumen diameter of target vessel at 6 months
restenosis rate 6 months the rate of re-stenosis (≥50) of target vessel at 6 months
6-month patency rate 6 months the 6-month patency rate of target vessel
main amputation 12 months rate of main amputation
Trial Locations
- Locations (1)
Renji Hospital
🇨🇳Shanghai, Shanghai, China