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

San Donato Group (GSD)

Status and phase

Unknown

Phase 4

Conditions

Peripheral Artery Disease

Treatments

Device: PEB

Device: PES

Study type

Interventional

Funder types

Other

Identifiers

NCT01969630

Arezzo011

Details and patient eligibility

About

To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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