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

NCT ID: NCT01938872

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Critical Limb Ischemia

Keywords

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critical limb ischemia drug-eluting balloon restenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PEB angioplasty

paclitaxel eluting balloon angioplasty in below-the-knee lesions

paclitaxel eluting balloon angioplasty in below-the-knee lesions

Intervention Type PROCEDURE

Interventions

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paclitaxel eluting balloon angioplasty in below-the-knee lesions

Intervention Type PROCEDURE

Other Intervention Names

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FREEWAY™ (Eurocor GmbH)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Donato

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Bolognese, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Francesco Liistro, MD

Role: primary

Other Identifiers

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Arezzo010

Identifier Type: -

Identifier Source: org_study_id