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

Bayer

Status and phase: Terminated; Phase 2

Conditions: PAD; Infrapopliteal Lesions

Treatments: Device: Standard balloon angioplasty; Device: Cotavance Paclitaxel Coated Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01260870

EURO CANAL

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with CLI

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Cotavance

Experimental group

Treatment:

Device: Cotavance Paclitaxel Coated Balloon

Standard balloon angioplasty

Active Comparator group

Description:

POBA

Treatment:

Device: Standard balloon angioplasty