Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

March 3, 2026 updated by: Warren J. Gasper, MD
This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

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 Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • Recruiting
        • Division of Vascular Surgery, SFVAMC
        • Principal Investigator:
          • Warren J Gasper, MD
        • Sub-Investigator:
          • Linda M Reilly, 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

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

Description

Inclusion Criteria

  1. Aortic aneurysms:

    • greater than or equal to 6 cm in diameter in men,
    • greater than or equal to 5.5 cm in diameter in women,
    • and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,
    • and/or iliac aneurysms larger than 4 cm in diameter.
  2. Anticipated mortality comparable to published rates with conventional surgical treatment.
  3. Life expectancy more than 2 years.
  4. Ability to give informed consent.
  5. Willingness to comply with follow-up schedule.
  6. Suitable arterial anatomy for endovascular repair.

Exclusion Criteria

  1. Free rupture of the aneurysm.
  2. Pregnancy.
  3. Known allergy to Nitinol, stainless steel, or polyester.
  4. Unwillingness or inability to comply with the follow up schedule.
  5. Serious systemic or groin infection.
  6. Uncorrectable coagulopathy.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).
Device: Endovascular Branched Stent-Graft
Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful implantation of TAAA branched stent-graft.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Long term success of TAAA branched stent-graft treatment.
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Warren J. Gasper, MD

Investigators

  • Principal Investigator: Warren J Gasper, MD, University of California, San Francisco

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

May 1, 2005

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 5, 2007

First Submitted That Met QC Criteria

June 5, 2007

First Posted (Estimated)

June 6, 2007

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-02810

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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