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NCT Number: NCT00483249

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Vascular Surgery, SFVAMC, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Anticipated mortality comparable to published rates with conventional surgical treatment.
  • Life expectancy more than 2 years.
  • Ability to give informed consent.
  • Willingness to comply with follow-up schedule.
  • Suitable arterial anatomy for endovascular repair.

Exclusion criteria

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

Treatment and study plan

Endovascular Branched Stent-Graft

Device

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

Primary outcomes

  1. Successful implantation of TAAA branched stent-graft.

    Time frame: 1 month

Secondary outcomes

  1. Long term success of TAAA branched stent-graft treatment.

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Madeleine L Clinch

CONTACT

[email protected]

415-353-4367

Warren J Gasper, MD

CONTACT

[email protected]

415 750 2115

Sponsors and collaborators

Lead sponsor

Warren J. Gasper, MD

Other

Registry information

Important dates

Study start
2005
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2007
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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