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

Phase 4

• Conditions: Peripheral Artery Disease
• Interventions: Device: PES; Device: PEB

• Registration Number: NCT01969630
• Lead Sponsor: Ospedale San Donato

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-10
• Study Start: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Last Update Submitted: 2013-10-21
• Study First Posted: 2013-10-25
• Last Update Posted: 2013-10-25
• Primary Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PES	PES	Systematic PES angioplasty
PEB	PEB	PEB angioplasty plus provisional nitinol stent implantation

Primary Outcome Measures

Name	Time	Method
angiographic binary restenosis	12 months	incidence of binary restenosis

Secondary Outcome Measures

Name	Time	Method
Composite of all cause mortality, major amputation and target lesion revascularization.	12 months	incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization.

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy