Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Bayer terminated the program and sold the IP to Medronic)
Information provided by (Responsible Party):
MEDRAD, Inc. Identifier:
First received: December 13, 2010
Last updated: September 19, 2014
Last verified: September 2014

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.

Condition Intervention Phase
Device: Cotavance Paclitaxel Coated Balloon
Device: Standard balloon angioplasty
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia

Resource links provided by NLM:

Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • Evaluate procedural safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identify and characterize therapeutic and functional endpoint assessments [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cotavance Device: Cotavance Paclitaxel Coated Balloon
Active Comparator: Standard balloon angioplasty
Device: Standard balloon angioplasty


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with CLI

Exclusion Criteria:

  • Participation in another research trial
  • Medical conditions the study doctor will assess
  Contacts and Locations
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Please refer to this study by its identifier: NCT01260870

Medical University
Graz, Austria
AZ St.-Blasius Hospital
Dendermonde, Belgium
University Hospital
Gent, Belgium
University Hospital
Bern, Switzerland
University Hospital
Zurich, Switzerland
United Kingdom
St. George's Hospital
London, United Kingdom
Sponsors and Collaborators
Principal Investigator: Nicolas Diehm, MD University of Bern
  More Information

No publications provided

Responsible Party: MEDRAD, Inc. Identifier: NCT01260870     History of Changes
Other Study ID Numbers: EURO CANAL
Study First Received: December 13, 2010
Last Updated: September 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Austria: Federal Office for Safety in Health Care
Switzerland: Swissmedic processed this record on March 03, 2015