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

NCT ID: NCT01260870

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-15

Study Completion Date

2013-07-15

Brief Summary

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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

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Conditions

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PAD Infrapopliteal Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cotavance

Group Type EXPERIMENTAL

Cotavance Paclitaxel Coated Balloon

Intervention Type DEVICE

Standard balloon angioplasty

POBA

Group Type ACTIVE_COMPARATOR

Standard balloon angioplasty

Intervention Type DEVICE

Interventions

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Cotavance Paclitaxel Coated Balloon

Intervention Type DEVICE

Standard balloon angioplasty

Intervention Type DEVICE

Other Intervention Names

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DEB POBA

Eligibility Criteria

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Inclusion Criteria

\- Subjects with CLI

Exclusion Criteria

* Participation in another research trial
* Medical conditions the study doctor will assess
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Medical University

Graz, , Austria

Site Status

AZ St.-Blasius Hospital

Dendermonde, , Belgium

Site Status

University Hospital

Ghent, , Belgium

Site Status

University Hospital

Bern, , Switzerland

Site Status

University Hospital

Zurich, , Switzerland

Site Status

St. George's Hospital

London, , United Kingdom

Site Status

Countries

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Austria Belgium Switzerland United Kingdom

Other Identifiers

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EURO CANAL

Identifier Type: -

Identifier Source: org_study_id

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