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Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00483249
First received: June 5, 2007
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Thoracoabdominal Aortic Aneurysm
Paravisceral Abdominal Aortic Aneurysm
 Device: Endovascular Branched Stent-Graft
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Successful implantation of TAAA branched stent-graft. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long term success of TAAA branched stent-graft treatment. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: May 2005
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endovascular Branched Stent-Graft
    Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483249

Contacts
Contact: Linda M Reilly, MD 415 353 4366 linda.reilly@ucsfmedctr.org
Contact: Timothy AM Chuter, MD 415 353 4366 timothy.chuter@ucsfmedctr.org

Locations
United States, California
Division of Vascular Surgery, UCSF Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Timothy AM Chuter, MD            
Principal Investigator: Linda M Reilly, MD            
Sub-Investigator: Jade S Hiramoto, MD            
Division of Vascular Surgery, SFVAMC Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Joseph H Rapp, MD            
Principal Investigator: Timothy AM Chuter, MD            
Principal Investigator: Linda M Reilly, MD            
Sub-Investigator: Marlene Grenon, MD            
Sponsors and Collaborators
University of California, San Francisco
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00483249     History of Changes
Other Study ID Numbers: H5357-26067
Study First Received: June 5, 2007
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Thoracoabdominal
Paravisceral
Aneurysm
Endovascular
Stent-Graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 21, 2013