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NCT01260870 Clinical Trial

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

PAD Clinical Trial

Official title:
European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01260870
Other study ID # EURO CANAL
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 15, 2011
Est. completion date July 15, 2013

Study information
Verified date January 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 44
Est. completion date July 15, 2013
Est. primary completion date July 15, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with CLI Exclusion Criteria: - Participation in another research trial - Medical conditions the study doctor will assess

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cotavance Paclitaxel Coated Balloon

• Standard balloon angioplasty

Locations
Country Name City State
Austria Medical University Graz
Belgium AZ St.-Blasius Hospital Dendermonde
Belgium University Hospital Gent
Switzerland University Hospital Bern
Switzerland University Hospital Zurich
United Kingdom St. George's Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate procedural safety 30 days
Secondary Identify and characterize therapeutic and functional endpoint assessments 5 years
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