stop_circleTerminated/Withdrawn

PAD, Infrapopliteal Lesions

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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Subjects with CLI
  • - Participation in another research trial
    - Medical conditions the study doctor will assess

Trial summary

Enrollment Goal
44
Trial Dates
August 2011 - July 2013
Phase
Phase 2
Could I Receive a placebo
No
Products
Paclitaxel-coated balloon catheters
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Medical UniversityGraz, Austria
Recruiting
University HospitalBern, Switzerland
Recruiting
University HospitalZurich, Switzerland
Recruiting
AZ St.-Blasius HospitalDendermonde, Belgium
Recruiting
University HospitalGent, Belgium
Recruiting
St. George's HospitalLondon, UK

Primary Outcome

  • Evaluate procedural safety
    date_rangeTime Frame:
    30 days
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Identify and characterize therapeutic and functional endpoint assessments
    date_rangeTime Frame:
    5 years
    enhanced_encryption
    Safety Issue:
    Yes

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