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Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Official Title:
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic AneurysmBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 1/Phase 2 | Interventional | N/A and older | University of California, San Francisco |
H5357-26067 NCT00483249 |
Recruiting |
Study Design:
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy StudyPrincipal Investigator
Linda M. Reilly, M.D.
Professor of Surgery
Director, General Surgery Residency Program
Trial 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
Inclusion Criteria:
- Aneurysm >6cm in diameter or >5cm in diameter which is enlarging at a rate of
>10mm/year - Anticipated mortality > 20% with conventional surgical treatment
- Life expectancy > 2 years
- Absence of a dominant artery to the spinal cord arising from the are of stent-graft
implantation - Ability to give informed consent and willingness to comply with follow-up schedule
- Suitable arterial anatomy for endovascular repair
Exclusion Criteria:
- Free rupture of the aneurysm
- Pregnancy
- Anaphylactic reaction to contrast material
- Allergy to stainless steel or polyester
- Unwillingness or inability to comply with the follow up schedule
- Serious systemic or groin infection
- Uncorrectable coagulopathy
- Inability to give informed consent in English
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.
Important
Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.
For More Information
For questions about this trial or eligibility, please contact:
Johanna Garcia
Clinical Research Coordinator
UCSF Vascular Surgery
415-353-4379 Office
415-353-4370 Fax
Johanna.Garcia@ucsfmedctr.org
Leyla Herrera
Clinical Research Coordinator
UCSF Vascular Surgery
415-353-4367 Office
415-353-4370 Fax
Leyla.Herrera@ucsfmedctr.org