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

September 5, 2013 updated by: Leonardo Bolognese, MD, Ospedale San Donato
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Recruiting
        • Cardiovascular Department, Ospedale S.Donato
        • Principal Investigator:
          • Leonardo Bolognese, MD, FESC
        • Contact:
        • Sub-Investigator:
          • Giovanni Falsini, MD
        • Sub-Investigator:
          • Paolo Angioli, MD
        • Sub-Investigator:
          • Kenneth Ducci, MD
        • Principal Investigator:
          • Francesco Liistro, MD
        • Sub-Investigator:
          • Simone Grotti, MD
        • Sub-Investigator:
          • Italo Porto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing below-the-knee angioplasty with paclitaxel eluting balloon for critical limb ischemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PEB angioplasty
paclitaxel eluting balloon angioplasty in below-the-knee lesions
Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesions
Other Names:
  • FREEWAY™ (Eurocor GmbH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiographic binary restenosis
Time Frame: 12 months
incidence of binary restenosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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