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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00483249 |
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 |
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Thoracoabdominal Aortic Aneurysm Paravisceral Abdominal Aortic Aneurysm |
Device: Endovascular Branched Stent-Graft |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm |
Estimated Enrollment: | 55 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Timothy AM Chuter, MD | 415 353 4366 | chutert@surgery.ucsf.edu |
Contact: Linda M Reilly, MD | 415 353 4366 | reillyl@surgery.ucsf.edu |
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: Darren B Schneider, 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 |
Responsible Party: | UCSF ( Linda M. Reilly, MD ) |
Study ID Numbers: | H5357-26067 |
Study First Received: | June 5, 2007 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00483249 |
Health Authority: | United States: Food and Drug Administration |
Thoracoabdominal Paravisceral Aneurysm Endovascular Stent-Graft |
Aortic Diseases Aortic Aneurysm, Thoracic Aneurysm Aortic Aneurysm, Abdominal |
Abdominal aortic aneurysm Vascular Diseases Aortic Aneurysm |
Cardiovascular Diseases |