Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Target lesion patency at 6-month follow-up.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •participation in another investigational drug or device trial
- •life expectancy less than 12 months
- •acute ischemia and/or acute thrombosis of the SFA/PPA
Outcomes
Primary Outcomes
Target lesion patency at 6-month follow-up.
Time Frame: 6-month post index procedure
Patency of target lesion at 6-month follow-up based on duplex ultrasound.
Secondary Outcomes
- Clinical success up to 12 months post index procedure(12 months post index procedure)