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Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

This study is currently recruiting participants.
Verified February 2017 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483249
First Posted: June 6, 2007
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Resource links provided by NLM:


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 ]

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

Estimated Enrollment: 250
Study Start Date: May 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
Endovascular Branched Stent-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).
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483249


Contacts
Contact: Linda M Reilly, MD 415 353 4366 linda.reilly2@ucsf.edu
Contact: Warren J Gasper, MD 415 750 2115 warren.gasper@ucsf.edu

Locations
United States, California
Division of Vascular Surgery, SFVAMC Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Warren J Gasper, MD         
Principal Investigator: Linda M Reilly, MD         
Division of Vascular Surgery, UCSF Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Linda M Reilly, MD         
Principal Investigator: Warren J Gasper, MD         
Sub-Investigator: Timothy AM Chuter, MD         
Sub-Investigator: Jade S Hiramoto, MD         
Sub-Investigator: Shant M Vartanian, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Linda M Reilly, MD University of California, San Francisco
  More Information

Publications:

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: 10-02810
First Submitted: June 5, 2007
First Posted: June 6, 2007
Last Update Posted: February 6, 2017
Last Verified: February 2017

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

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