Recruiting

Endovascular Exclusion

Sponsor:

Warren J. Gasper, MD

Code:

NCT00483249

Conditions

Thoracoabdominal Aortic Aneurysm

Paravisceral Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endovascular Branched Stent-Graft

Study Details

Brief summary:

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.

Conditions

Thoracoabdominal Aortic Aneurysm

Paravisceral Abdominal Aortic Aneurysm

Study ID

NCT00483249

Start date

May, 2005

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Endovascular Branched Stent-Graft

Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.

Primary outcome measure

  • Successful implantation of TAAA branched stent-graft. [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Warren J Gasper, MD

415 750 2115warren.gasper@ucsf.edu

Madeleine L Clinch

415-353-4367Madeleine.Clinch@ucsf.edu

Locations

Division of Vascular Surgery, SFVAMC

Recruiting

San Francisco, California, United States, 94121

Principal Investigator:

Warren J Gasper, MD

Division of Vascular Surgery, UCSF

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Warren J Gasper, MD

More Information

Sponsor

Warren J. Gasper, MD

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Thoracoabdominal
  • Paravisceral
  • Aneurysm
  • Endovascular
  • Stent-Graft
  • Aorta

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Warren J. Gasper, MD on 2026-03-05.