Cook Iliac Branch Graft Post-market Registry

This study has been terminated.
(Terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01055275
First received: January 22, 2010
Last updated: June 19, 2013
Last verified: June 2013
  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:


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 ]

Enrollment: 2
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
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: June 19, 2013
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 July 24, 2014