Thoracoabdominal Aortic Aneurysm Clinical Trial
Official title:
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
NCT number | NCT00483249 |
Other study ID # | 10-02810 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2005 |
Est. completion date | December 2026 |
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Division of Vascular Surgery, SFVAMC | San Francisco | California |
United States | Division of Vascular Surgery, UCSF | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Timothy Chuter, MD |
United States,
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Fernandez CC, Sobel JD, Gasper WJ, Vartanian SM, Reilly LM, Chuter TA, Hiramoto JS. Standard off-the-shelf versus custom-made multibranched thoracoabdominal aortic stent grafts. J Vasc Surg. 2016 May;63(5):1208-15. doi: 10.1016/j.jvs.2015.11.035. Epub 2016 Jan 24. — View Citation
Gasper WJ, Reilly LM, Rapp JH, Grenon SM, Hiramoto JS, Sobel JD, Chuter TA. Assessing the anatomic applicability of the multibranched endovascular repair of thoracoabdominal aortic aneurysm technique. J Vasc Surg. 2013 Jun;57(6):1553-8; discussion 1558. doi: 10.1016/j.jvs.2012.12.021. Epub 2013 Feb 6. — View Citation
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Ramanan B, Fernandez CC, Sobel JD, Gasper WJ, Vartanian SM, Reilly LM, Chuter TA, Hiramoto JS. Low-profile versus standard-profile multibranched thoracoabdominal aortic stent grafts. J Vasc Surg. 2016 Jul;64(1):39-45. doi: 10.1016/j.jvs.2016.01.038. Epub 2016 Mar 22. — View Citation
Reilly LM, Rapp JH, Grenon SM, Hiramoto JS, Sobel J, Chuter TA. Efficacy and durability of endovascular thoracoabdominal aortic aneurysm repair using the caudally directed cuff technique. J Vasc Surg. 2012 Jul;56(1):53-63; discussion 63-4. doi: 10.1016/j.jvs.2012.01.006. Epub 2012 May 3. — View Citation
Sobel JD, Vartanian SM, Gasper WJ, Hiramoto JS, Chuter TA, Reilly LM. Lower extremity weakness after endovascular aneurysm repair with multibranched thoracoabdominal stent grafts. J Vasc Surg. 2015 Mar;61(3):623-8. doi: 10.1016/j.jvs.2014.10.013. Epub 2014 Nov 25. — View Citation
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful implantation of TAAA branched stent-graft. | 1 month | ||
Secondary | Long term success of TAAA branched stent-graft treatment. | 5 years |
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