Vascular & Endovascular Surgery »  Research »  Clinical Research »  Clinical Trials »  10-02810 (TAAA/PVAAA)

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Official Title:

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 1/Phase 2 Interventional 18 Years and older University of California, San Francisco 10-02810
NCT00483249
Enrolling patients

Study Design:


Principal Investigator

Professor of Surgery
Division of Vascular & Endovascular Surgery
Director, General Surgery Residency Program
Department of Surgery

Clinical Research Coordinator

UCSF Medical Center at Parnassus
(415) 353-4367 Phone
(415) 353-4370 Fax

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

     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.

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.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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