Cook Iliac Branch Graft Post-market Registry

June 19, 2013 updated by: Cook Group Incorporated
The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with a Cook Iliac Branch Graft.

Description

Inclusion Criteria:

  • CE-Marked Cook Iliac Branch Graft (e.g., Zenith® Branch Endovascular Graft-Iliac Bifurcation, Zenith® Helical Branch Endovascular Graft)
  • Registry data are de-identified with respect to patient.

Exclusion Criteria:

  • Patient for whom this device would not normally be considered standard of care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cook Iliac Branch Graft
Patients implanted with a Cook Iliac Branch Graft
Device: Implantation with a Cook Iliac Branch Graft
Treatment of an aortic, aorto-iliac or iliac aneurysm with a CE-marked Cook Iliac Branch Graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Internal iliac artery patency
Time Frame: 1 year
1 year
Aneurysm Exclusion
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 1 year
1 year
Conversion
Time Frame: 1 year
1 year
Rupture
Time Frame: 1 year
1 year
Success Measures
Time Frame: 1 year
1 year
Major Complications
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Vincent Riambau, MD, PhD, Hospital Clinic, Barcelona, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe