Back to resultsEuropean Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
Primary Purpose
PAD
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cotavance Paclitaxel Coated Balloon
Standard balloon angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for PAD
Eligibility Criteria
Inclusion Criteria:
- Subjects with CLI
Exclusion Criteria:
- Participation in another research trial
- Medical conditions the study doctor will assess
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cotavance
Standard balloon angioplasty
Arm Description
POBA
Outcomes
Primary Outcome Measures
Evaluate procedural safety
Secondary Outcome Measures
Identify and characterize therapeutic and functional endpoint assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01260870
Brief Title
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
Official Title
European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Bayer terminated the program and sold the IP to Medronic
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cotavance
Arm Type
Experimental
Arm Title
Standard balloon angioplasty
Arm Type
Active Comparator
Arm Description
POBA
Intervention Type
Device
Intervention Name(s)
Cotavance Paclitaxel Coated Balloon
Intervention Description
DEB
Intervention Type
Device
Intervention Name(s)
Standard balloon angioplasty
Intervention Description
POBA
Primary Outcome Measure Information:
Title
Evaluate procedural safety
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Identify and characterize therapeutic and functional endpoint assessments
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Subjects with CLI
Exclusion Criteria:
Participation in another research trial
Medical conditions the study doctor will assess
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Graz
Country
Austria
City
Dendermonde
Country
Belgium
City
Gent
Country
Belgium
City
Bern
Country
Switzerland
City
Zurich
Country
Switzerland
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
We'll reach out to this number within 24 hrs