Paclitaxel Eluting Balloon for SFA In-stent Restenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries

Conditions
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In-stent Arterial Restenosis

Intervention / Treatment
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* Device: PTA with drug eluting balloon with paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm<br>SFA angioplasty with In.Pact Admiral drug eluting balloon | Device: PTA with drug eluting balloon with paclitaxel<br>* Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries<br>* Other names: In.Pact Admiral by Medtronic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion patency at 6-month follow-up. | Patency of target lesion at 6-month follow-up based on duplex ultrasound. | 6-month post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months post index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon with paclitaxel, in stent restenosis, femoropopliteal arteries, angioplasty