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

Phase 2

Terminated

• Conditions: PAD; Infrapopliteal Lesions
• Interventions: Device: Cotavance Paclitaxel Coated Balloon; Device: Standard balloon angioplasty

• Registration Number: NCT01260870
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Study Start: 2011-08-15
• Primary Completion: 2013-07-15
• Study Completion: 2013-07-15
• Disposition First Submitted: 2015-06-05
• Disposition First Submitted QC: 2015-06-05
• Disposition First Posted: 2015-07-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Subjects with CLI

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Exclusion Criteria

• Participation in another research trial
• Medical conditions the study doctor will assess

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cotavance	Cotavance Paclitaxel Coated Balloon	-
Standard balloon angioplasty	Standard balloon angioplasty	POBA

Primary Outcome Measures

Name	Time	Method
Evaluate procedural safety	30 days

Secondary Outcome Measures

Name	Time	Method
Identify and characterize therapeutic and functional endpoint assessments	5 years

Trial Locations

Locations (4)

Medical University; 🇦🇹 Graz, Austria

AZ St.-Blasius Hospital; 🇧🇪 Dendermonde, Belgium

University Hospital; 🇨🇭 Zurich, Switzerland

St. George's Hospital; 🇬🇧 London, United Kingdom