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RecruitingNot ApplicableNCT00483249

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Sponsor

Warren J. Gasper, MD

Enrollment

250 participants

Start Date

May 1, 2005

Study Type

INTERVENTIONAL

Conditions

Thoracoabdominal Aortic AneurysmParavisceral Abdominal Aortic Aneurysm

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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 Criteria6

  • 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.
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Interventions

DEVICEEndovascular Branched Stent-Graft

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

Locations(2)

Division of Vascular Surgery, SFVAMC

San Francisco, California, United States

Division of Vascular Surgery, UCSF

San Francisco, California, United States

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NCT00483249

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