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

San Donato Group (GSD)

Status: Unknown

Conditions: Critical Limb Ischemia

Treatments: Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesions

Study type: Observational

Funder types: Other

Identifiers

NCT01938872

Arezzo010

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

PEB angioplasty

Description:

paclitaxel eluting balloon angioplasty in below-the-knee lesions

Treatment:

Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesions