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

Ospedale San Donato1 site in 1 country250 target enrollmentOctober 2013

ConditionsPeripheral Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Ospedale San Donato
Enrollment: 250
Locations: 1
Primary Endpoint: angiographic binary restenosis
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

October 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ospedale San Donato

Responsible Party

Principal Investigator

Leonardo Bolognese, MD

Director

Ospedale San Donato

Eligibility Criteria

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