Terminated/Withdrawn

PAD, Infrapopliteal Lesions

Bayer Identifier:

EURO CANAL

ClinicalTrials.gov Identifier:

NCT01260870

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

Both

Age

18 - N/A

Trial summary

Enrollment Goal

Trial Dates

August 2011 - July 2013

Phase

Phase 2

Could I Receive a placebo

Products

Paclitaxel-coated balloon catheters

Accepts Healthy Volunteer

Where 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 safety
Time Frame:
30 days
Safety Issue:
Yes

Secondary Outcome

Identify and characterize therapeutic and functional endpoint assessments
Time Frame:
5 years
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

Additional Information

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