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

• Conditions: Critical Limb Ischemia
• Interventions: Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesions

• Registration Number: NCT01938872
• Lead Sponsor: Ospedale San Donato

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Study First Posted: 2013-09-10
• Last Update Posted: 2013-09-10
• Primary Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEB angioplasty	paclitaxel eluting balloon angioplasty in below-the-knee lesions	paclitaxel eluting balloon angioplasty in below-the-knee lesions

Primary Outcome Measures

Name	Time	Method
angiographic binary restenosis	12 months	incidence of binary restenosis

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy