Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia

N/AUnknownNCT01938872

Ospedale San Donato100 enrolled

Overview

to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Critical Limb Ischemia

Interventions

paclitaxel eluting balloon angioplasty in below-the-knee lesionsPROCEDURE

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

angiographic binary restenosis

incidence of binary restenosis

Time frame: 12 months

Data from ClinicalTrials.gov

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