Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

October 31, 2014 updated by: Leonardo Bolognese, MD, Ospedale San Donato
The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

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

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Freeway
angioplasty with Freeway drug-eluting balloon
Device: Freeway PTA
angioplasty with Freeway drug-eluting balloon
Experimental: Lutonix
angioplasty with Lutonix drug-eluting balloon
Device: Lutonix PTA
angioplasty with Lutonix drug-eluting balloon

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of events of target lesion revascularization
Time Frame: 12 months
number of events of target lesion revascularization
12 months
number of events of death
Time Frame: 12 months
number of events of death
12 months
frequency of major amputation
Time Frame: 12 months
frequency of major amputation
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

October 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo013

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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