Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

August 11, 2023 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • Recruiting
        • Division of Vascular Surgery, SFVAMC
        • Sub-Investigator:
          • Linda M Reilly, MD
        • Sub-Investigator:
          • Timothy AM Chuter, MD
        • Contact:
          • Shelley Dwyer, RN
          • Phone Number: 415-750-2115
        • Principal Investigator:
          • Joseph H Rapp, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • Division of Vascular Surgery, UCSF
        • Principal Investigator:
          • Warren J Gasper, MD
        • Sub-Investigator:
          • Linda M Reilly, MD
        • Sub-Investigator:
          • Timothy AM Chuter, MD
        • Sub-Investigator:
          • Jade S Hiramoto, MD
        • Sub-Investigator:
          • Shant M Vartanian, MD
        • Contact:
          • Diana Kim, MPH
          • Phone Number: 415-353-4366
        • Sub-Investigator:
          • Darren B Schneider, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Abdominal Aortic Aneurysms treated with Zenith Stent-Graft

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimated)

June 20, 2007

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H53537-26003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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