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Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00488943
First Posted: June 20, 2007
Last Update Posted: July 2, 2012
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):
University of California, San Francisco
  Purpose
To collect and analyze clinical follow-up data which can be used to assess the safety, efficacy, and durability of endovascular AAA repair with Zenith and Chuter-Gianturco stent-grafts.

Condition Intervention
Abdominal Aortic Aneurysm Device: AAA Endovascular Bifurcated Stent-Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Enrollment: 300
Study Start Date: January 2005
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AAA Endovascular Bifurcated Stent-Graft
    Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft.
    Other Name: Zenith AAA Endovascular Stent-Graft (Cook, Inc.)
Detailed Description:
We propose to analyze the data collected for clinical purposes in 453 patients who already underwent endovascular AAA repair at UCSF and SFVA, and others who will undergo this operation in the future. Most of these patients have now passed the 2-year follow-up required by the original protocol, all continue to be followed for clinical purposes, using the same studies, the same data forms and the same schedule as before, because studies of various devices of this type have shown that the potential for late problems requires continuing scrutiny of stent-graft structure and function, as a basis for timely re-intervention.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Abdominal Aortic Aneurysms treated with Zenith Stent-Graft
Criteria

Inclusion Criteria:

  • AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year
  • treatment of AAA with Zenith Stent-Graft

Exclusion Criteria:

  • Pregnant
  • Life expectancy less than two years
  • Less than 18 years of age
  • Unwilling to comply with clinical follow-up schedule
  • Inability or refusal to give informed consent
  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): NCT00488943


Locations
United States, California
Division of Vascular Surgery, SFVAMC
San Francisco, California, United States, 94121
Division of Vascular Surgery, UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Timothy AM Chuter, MD Professor of Surgery
Principal Investigator: Joseph H Rapp, MD Professor of Surgery
Principal Investigator: Linda M Reilly, MD Professor of Surgery
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00488943     History of Changes
Other Study ID Numbers: H53537-26003
First Submitted: June 18, 2007
First Posted: June 20, 2007
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by University of California, San Francisco:
Stent-Graft
AAA
Abdominal Aortic Anuerysm
Zenith
Endovascular
Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases