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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by MEDRAD, Inc.
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01260870
First received: December 13, 2010
Last updated: July 10, 2012
Last verified: July 2012
  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 ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2012 (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

Contacts
Contact: Jim Gustafson jim.gustafson@bayer.com

Locations
Austria
Medical University Recruiting
Graz, Austria
Sub-Investigator: Marianne Brodmann, MD         
Principal Investigator: Ernst Pilger, MD         
Belgium
AZ St.-Blasius Hospital Recruiting
Dendermonde, Belgium
Principal Investigator: Marc Bosiers, MD         
University Hospital Recruiting
Gent, Belgium
Principal Investigator: Frank Vermassen, MD         
Switzerland
University Hospital Recruiting
Bern, Switzerland
Principal Investigator: Nicolas Diehm, MD         
University Hospital Recruiting
Zurich, Switzerland
Principal Investigator: Marc Husmann, MD         
United Kingdom
St. George's Hospital Recruiting
London, United Kingdom
Principal Investigator: Anna-Maria Belli, MD         
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: July 10, 2012
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:
Ischemia
Pathologic Processes
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014