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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01938872

Enrollment

100

Registered

2013-09-10

Start date

2013-09-30

Completion date

Unknown

Last updated

2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

Keywords

critical limb ischemia, drug-eluting balloon, restenosis

Brief summary

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

Interventions

PROCEDUREpaclitaxel eluting balloon angioplasty in below-the-knee lesions

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
angiographic binary restenosis	12 months	incidence of binary restenosis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026