We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01260870
First Posted: December 15, 2010
Last Update Posted: July 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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
PAD Device: Cotavance Paclitaxel Coated Balloon Device: Standard balloon angioplasty Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Identify and characterize therapeutic and functional endpoint assessments [ Time Frame: 5 years ]

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
DEB
Active Comparator: Standard balloon angioplasty
POBA
Device: Standard balloon angioplasty
POBA

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Subjects with CLI

Exclusion Criteria:

  • Participation in another research trial
  • Medical conditions the study doctor will assess
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260870


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01260870     History of Changes
Other Study ID Numbers: EURO CANAL
First Submitted: December 13, 2010
First Posted: December 15, 2010
Last Update Posted: July 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action