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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries
University Health Network
Toronto, Ontario, Canada
Target lesion patency at 6-month follow-up.
Patency of target lesion at 6-month follow-up based on duplex ultrasound.
Time frame: 6-month post index procedure
Clinical success up to 12 months post index procedure
Improvement on clinical evaluations including staging of PAD according to the Rutherford category, ABI at 1, 6, 12 months post procedure compared to baseline assessment.
Time frame: 12 months post index procedure
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