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

San Donato Group (GSD)

Status and phase: Unknown; Phase 4

Conditions: Peripheral Artery Disease

Treatments: Device: Freeway PTA; Device: Lutonix PTA

Study type: Interventional

Funder types: Other

Identifiers

NCT02279784

Arezzo013

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Freeway

Experimental group

Description:

angioplasty with Freeway drug-eluting balloon

Treatment:

Device: Freeway PTA

Lutonix

Experimental group

Description:

angioplasty with Lutonix drug-eluting balloon

Treatment:

Device: Lutonix PTA