PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis (PLAISIR)

Inclusion Criteria:

• Age ≥18 years old
• Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5
• Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions
• Symptoms related to SFA ISR defined by PSVR > 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study
• The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection)
• Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery)
• The target lesion must no extend beyond the stent margin
• Successful crossing of the target lesion, inflow and outflow lesions with a guidewire
• Patient belongs to the French health care system
• Written informed consent

Exclusion Criteria:

• No atheromatous disease
• Asymptomatic lesion
• Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel
• Acute limb ischemia
• Patient on oral anticoagulation therapy
• Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc.
• Life expectancy < 1 year
• Patient involved in another trial
• Refusing patient
• Pregnancy