Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

Inclusion Criteria:

• Patients over 18 years with critical lower limb ischemia,
• Ruhtherford 3 or higher,
• with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery,
• with a maximum extension of 10 cm stenosis.
• The popliteal artery and at least one leg artery must be patent.

Exclusion Criteria:

• Pregnancy,
• thrombophilia,
• coagulation disorders,
• presence of active or recent bleeding,
• severe allergy to iodinated contrast,
• renal or hepatic disease,
• acute limb ischemia,
• prior surgical bypass or angioplasty (with or without stent) on the target artery,
• obstructive disease (stenosis> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)