Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

Phase 4

• Conditions: Peripheral Artery Disease
• Interventions: Device: Freeway PTA; Device: Lutonix PTA

• Registration Number: NCT02279784
• Lead Sponsor: Ospedale San Donato

Brief Summary

The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.

Detailed Description

Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-31
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-02
• Primary Completion: 2015-12
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• age>18 years
• angiographic stenosis>50% or occlusion of one below-knee vessel

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freeway	Freeway PTA	angioplasty with Freeway drug-eluting balloon
Lutonix	Lutonix PTA	angioplasty with Lutonix drug-eluting balloon

Primary Outcome Measures

Name	Time	Method
number of events of angiographic binary restenosis	12 months	number of events of angiographic binary restenosis

Secondary Outcome Measures

Name	Time	Method
frequency of major amputation	12 months	frequency of major amputation
number of events of target lesion revascularization	12 months	number of events of target lesion revascularization
number of events of death	12 months	number of events of death

Trial Locations

Locations (1)

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