Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
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ClinicalTrials.gov Identifier: NCT00483249 |
Recruitment Status
:
Recruiting
First Posted
: June 6, 2007
Last Update Posted
: January 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Thoracoabdominal Aortic Aneurysm Paravisceral Abdominal Aortic Aneurysm | Device: Endovascular Branched Stent-Graft | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm |
Study Start Date : | May 2005 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
---|---|
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).
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Device: Endovascular Branched Stent-Graft
Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
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- Successful implantation of TAAA branched stent-graft. [ Time Frame: 1 month ]
- Long term success of TAAA branched stent-graft treatment. [ Time Frame: 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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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.
- Anticipated mortality comparable to published rates with conventional surgical treatment.
- Life expectancy more than 2 years.
- Ability to give informed consent.
- Willingness to comply with follow-up schedule.
- Suitable arterial anatomy for endovascular repair.
Exclusion Criteria
- Free rupture of the aneurysm.
- Pregnancy.
- Known allergy to Nitinol, stainless steel, or polyester.
- Unwillingness or inability to comply with the follow up schedule.
- Serious systemic or groin infection.
- Uncorrectable coagulopathy.

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
Contact: Linda M Reilly, MD | 415 353 4366 | linda.reilly2@ucsf.edu | |
Contact: Warren J Gasper, MD | 415 750 2115 | warren.gasper@ucsf.edu |
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 |
Principal Investigator: | Linda M Reilly, MD | University of California, San Francisco |
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 Posted: | June 6, 2007 Key Record Dates |
Last Update Posted: | January 9, 2018 |
Last Verified: | January 2018 |
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 |