European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)

January 29, 2024 updated by: Bayer

European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia

To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

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

  • Austria
      • Graz, Austria
        • Medical University
  • Belgium
      • Dendermonde, Belgium
        • AZ St.-Blasius Hospital
      • Gent, Belgium
        • University Hospital
  • Switzerland
      • Bern, Switzerland
        • University Hospital
      • Zurich, Switzerland
        • University Hospital
  • United Kingdom
      • London, United Kingdom
        • St. George's Hospital

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

Description

Inclusion Criteria:

- Subjects with CLI

Exclusion Criteria:

  • Participation in another research trial
  • Medical conditions the study doctor will assess

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cotavance
Device: Cotavance Paclitaxel Coated Balloon
Other Names:
  • DEB
Active Comparator: Standard balloon angioplasty
POBA
Device: Standard balloon angioplasty
Other Names:
  • POBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate procedural safety
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify and characterize therapeutic and functional endpoint assessments
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

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 (Actual)

August 15, 2011

Primary Completion (Actual)

July 15, 2013

Study Completion (Actual)

July 15, 2013

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimated)

December 15, 2010

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EURO CANAL

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.

Subscribe