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

Phase 2TerminatedNCT01260870

Bayer44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PAD Infrapopliteal Lesions

Interventions

Cotavance Paclitaxel Coated BalloonDEVICE

Standard balloon angioplastyDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Subjects with CLI Exclusion Criteria: * Participation in another research trial * Medical conditions the study doctor will assess

Locations (6)

Medical University

Graz, Austria

AZ St.-Blasius Hospital

Dendermonde, Belgium

University Hospital

Ghent, Belgium

University Hospital

Bern, Switzerland

University Hospital

Outcomes

Primary Outcomes

Evaluate procedural safety

Time frame: 30 days

Secondary Outcomes

Identify and characterize therapeutic and functional endpoint assessments

Time frame: 5 years

Data from ClinicalTrials.gov

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