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:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01260870
First received: December 13, 2010
Last updated: September 19, 2014
Last verified: September 2014
  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
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
DEB
Active Comparator: Standard balloon angioplasty
POBA
Device: Standard balloon angioplasty
POBA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260870

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

No publications provided

Responsible Party: MEDRAD, Inc.
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014