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):
Bayer Identifier:
First received: December 13, 2010
Last updated: June 5, 2015
Last verified: June 2015
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 Bayer:

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

Graz, Austria
Dendermonde, Belgium
Gent, Belgium
Bern, Switzerland
Zurich, Switzerland
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT01260870     History of Changes
Other Study ID Numbers: EURO CANAL 
Study First Received: December 13, 2010
Last Updated: June 5, 2015
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

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on February 04, 2016