Drug Eluting Balloon in peripherAl inTErvention SFA

Leonardo Bolognese, MD104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Peripheral Arterial Disease

Interventions

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantationDEVICE

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

nitinol stent implantationDEVICE

nitinol stent implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age\>18 years * intermittent claudication(Fontane III or IV) * angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm * 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

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 months

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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