Trial record 1 of 174 for:    "Abdominal aortic aneurysm"
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Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00488943
First received: June 18, 2007
Last updated: June 28, 2012
Last verified: June 2012
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488943

Locations
United States, California
Division of Vascular Surgery, UCSF
San Francisco, California, United States, 94143
Division of Vascular Surgery, SFVAMC
San Francisco, California, United States, 94121
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
Study First Received: June 18, 2007
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014