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

Ospedale San Donato160 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Peripheral Artery Disease

Interventions

Freeway PTADEVICE

angioplasty with Freeway drug-eluting balloon

Lutonix PTADEVICE

angioplasty with Lutonix drug-eluting balloon

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, Italy

RECRUITING

Outcomes

Primary Outcomes

number of events of angiographic binary restenosis

Time frame: 12 months

Secondary Outcomes

number of events of target lesion revascularization

Time frame: 12 months

number of events of death

Time frame: 12 months

frequency of major amputation

Time frame: 12 months

Data from ClinicalTrials.gov

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