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.
Verified July 2012 by MEDRAD, Inc.
Sponsor:
MEDRAD, Inc.
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
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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:
MedlinePlus related topics:
Angioplasty
Drug Information available for:
Paclitaxel
U.S. FDA Resources
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
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 May 22, 2013