Trial Condition(s):
PAD
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
Bayer Identifier:
EURO CANAL
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
Inclusion Criteria
- Subjects with CLI
Exclusion Criteria
- Participation in another research trial - Medical conditions the study doctor will assess
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Medical University Graz, Austria | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospital Bern, Switzerland | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospital Zurich, Switzerland | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ St.-Blasius Hospital Dendermonde, Belgium | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospital Gent, Belgium | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. George's Hospital London, United Kingdom | Status Recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia
Trial Type:
Interventional
Intervention Type:
Device
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Evaluate procedural safetyTimeframe: 30 days
Secondary Outcome
- Identify and characterize therapeutic and functional endpoint assessmentsTimeframe: 5 years
Additional Information
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