Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis

Suspended

• Conditions: Peripheral Arterial Disease
• Interventions: Device: POBA; Device: DEB

• Registration Number: NCT01558531
• Lead Sponsor: Leonardo Bolognese, MD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-12
• Study First Submitted: 2012-03-17
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• age>18 years
• intermittent claudication (Fontane III or IV)
• angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm, previously treated with nitinol stent implantation, with 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
• need for amputation
• angiographic evidence of stent fracture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
conventional PTA	POBA	historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009)
DEB	DEB	paclitaxel-eluting balloon angioplasty

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
major amputation	24 months	incidence of major amputation
stent thrombosis	24 months	incidence of stent thrombosis
target lesion revascularization	24 months	incidence of target lesion revascularization

Trial Locations

Locations (1)

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