Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation

Leonardo Bolognese, MD142 enrolled

Overview

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

142

Conditions

Critical Limb Ischemia

Interventions

PEBDEVICE

paclitaxel-eluting balloon angioplasty

POBADEVICE

conventional balloon angioplasty

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

Outcomes

Primary Outcomes

angiographic binary restenosis

incidence of binary restenosis

Time frame: 12 months

Secondary Outcomes

major amputation

incidence of major amputation

Time frame: 24 motnhs

target lesion revascularization

incidence of target lesion revascularization

Time frame: 24 months

vessel reocclusion

incidence of vessel reocclusion

Time frame: 24 months

Data from ClinicalTrials.gov

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