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Cook Iliac Branch Graft Post-market Registry

This study has been terminated.
(Terminated due to low enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055275
First Posted: January 25, 2010
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
  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 Group Incorporated:

Primary Outcome Measures:
  • Internal iliac artery patency [ Time Frame: 1 year ]
  • Aneurysm Exclusion [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Death [ Time Frame: 1 year ]
  • Conversion [ Time Frame: 1 year ]
  • Rupture [ Time Frame: 1 year ]
  • Success Measures [ Time Frame: 1 year ]
  • Major Complications [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055275


Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Vincent Riambau, MD, PhD Hospital Clinic, Barcelona, Spain
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01055275     History of Changes
Other Study ID Numbers: 09-016
First Submitted: January 22, 2010
First Posted: January 25, 2010
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Cook Group Incorporated:
iliac aneurysm
aortic aneurysm
endovascular grafts

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