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Cook Iliac Branch Graft Post-market Registry

This study is currently recruiting participants.
Verified July 2012 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01055275
First received: January 22, 2010
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Iliac Aneurysm
Aortic Aneurysm
 Device: Implantation with a Cook Iliac Branch Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cook Iliac Branch Graft Post-market Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Internal iliac artery patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Aneurysm Exclusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Conversion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Rupture [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Success Measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Major Complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients implanted with a Cook Iliac Branch Graft.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055275

Contacts
Contact: Rachel Bell 765-463-7537 rbell@medinst.com

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Vincent Riambau, MD, PhD     349 3227 5515     riambau@meditex.es    
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Vincent Riambau, MD, PhD Hospital Clinic, Barcelona, Spain
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01055275     History of Changes
Other Study ID Numbers: 09-016
Study First Received: January 22, 2010
Last Updated: July 17, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Cook:
iliac aneurysm
aortic aneurysm
endovascular grafts

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Iliac Aneurysm
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 21, 2013