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

S

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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