Drug Eluting Balloon in peripherAl inTErvention SFA

Phase 4

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: nitinol stent implantation; Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

• Registration Number: NCT01556542
• Lead Sponsor: Leonardo Bolognese, MD

Brief Summary

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Primary Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-26
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• age>18 years
• intermittent claudication(Fontane III or IV)
• angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
• at least one below-knee vessel to the ankle

Exclusion Criteria

• allergy to Paclitaxel
• contraindication for combined antiplatelet treatment
• life expectancy <1 year
• hypersensitivity or contraindication to one of the study drugs
• lack of consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard PTA	nitinol stent implantation	nitinol stent implantation
DEB	paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation	paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
major amputation	24 months	incidence of major amputation
target lesion revascularization	24 months	incidence of target lesion revascularization
vessel reocclusion	24 months	incidence of vessel reocclusion

Trial Locations

Locations (1)

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