NCT01260870

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
4 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

August 15, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2013

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

December 13, 2010

Last Update Submit

January 29, 2024

Conditions

PADInfrapopliteal Lesions

Outcome Measures

Primary Outcomes (1)

  • Evaluate procedural safety

    30 days

Secondary Outcomes (1)

  • Identify and characterize therapeutic and functional endpoint assessments

    5 years

Study Arms (2)

Cotavance

EXPERIMENTAL
Device: Cotavance Paclitaxel Coated Balloon

Standard balloon angioplasty

ACTIVE COMPARATOR

POBA

Device: Standard balloon angioplasty

Interventions

Cotavance Paclitaxel Coated BalloonDEVICE
Also known as: DEB
Cotavance
Standard balloon angioplastyDEVICE
Also known as: POBA
Standard balloon angioplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Subjects with CLI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical University

Graz, Austria

Location

AZ St.-Blasius Hospital

Dendermonde, Belgium

Location

University Hospital

Ghent, Belgium

Location

University Hospital

Bern, Switzerland

Location

University Hospital

Zurich, Switzerland

Location

St. George's Hospital

London, United Kingdom

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 15, 2010

Study Start

August 15, 2011

Primary Completion

July 15, 2013

Study Completion

July 15, 2013

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

BE(2)AU(1)CH(2)GB(1)