stop_circleTerminated/Withdrawn
PAD, Infrapopliteal Lesions
Bayer Identifier:
EURO CANAL
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
BothAge
18 - N/ATrial summary
Enrollment Goal
44Trial Dates
August 2011 - July 2013Phase
Phase 2Could I Receive a placebo
NoProducts
Paclitaxel-coated balloon cathetersAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Medical University | Graz, Austria |
Recruiting | University Hospital | Bern, Switzerland |
Recruiting | University Hospital | Zurich, Switzerland |
Recruiting | AZ St.-Blasius Hospital | Dendermonde, Belgium |
Recruiting | University Hospital | Gent, Belgium |
Recruiting | St. George's Hospital | London, UK |
Primary Outcome
- Evaluate procedural safetydate_rangeTime Frame:30 daysenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Identify and characterize therapeutic and functional endpoint assessmentsdate_rangeTime Frame:5 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2