Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

Inclusion Criteria: * intermittent claudication or critical limb ischemia * de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries * presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk * presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis \>70%) Exclusion Criteria: * life expectancy \<1 year * contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel * need for major amputation (MA) at the time of enrolment * Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation