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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Details

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.

Keywords

Thoracoabdominal Aortic Aneurysm Paravisceral Abdominal Aortic Aneurysm Thoracoabdominal Paravisceral Aneurysm Endovascular Stent-Graft Aorta

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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.

Locations

  • Division of Vascular Surgery, SFVAMC accepting new patients
    San Francisco, California, 94121, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT00483249
Phase
Phase 1/2
Lead Scientist
Linda Reilly
Study Type
Interventional
Last Updated
February 1, 2017
I’m interested in this study!