NCT00483249

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2005Dec 2027

Study Start

First participant enrolled

May 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2007

Completed
20.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

22.6 years

First QC Date

June 5, 2007

Last Update Submit

March 3, 2026

Conditions

Thoracoabdominal Aortic AneurysmParavisceral Abdominal Aortic Aneurysm

Keywords

ThoracoabdominalParavisceralAneurysmEndovascularStent-GraftAorta

Outcome Measures

Primary Outcomes (1)

  • Successful implantation of TAAA branched stent-graft.

    1 month

Secondary Outcomes (1)

  • Long term success of TAAA branched stent-graft treatment.

    5 years

Study Arms (1)

Interventional

EXPERIMENTAL

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

Interventions

Endovascular Branched Stent-GraftDEVICE

Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Vascular Surgery, SFVAMC

San Francisco, California, 94121, United States

RECRUITING

Division of Vascular Surgery, UCSF

San Francisco, California, 94143, United States

RECRUITING

Related Publications (31)

  • Crawford ES, DeNatale RW. Thoracoabdominal aortic aneurysm: observations regarding the natural course of the disease. J Vasc Surg. 1986 Apr;3(4):578-82. doi: 10.1067/mva.1986.avs0030578.

    PMID: 3959256BACKGROUND

  • Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.

    PMID: 8433431BACKGROUND

  • Martin GH, O'Hara PJ, Hertzer NR, Mascha EJ, Krajewski LP, Beven EG, Clair DG, Ouriel K. Surgical repair of aneurysms involving the suprarenal, visceral, and lower thoracic aortic segments: early results and late outcome. J Vasc Surg. 2000 May;31(5):851-62. doi: 10.1067/mva.2000.106481.

    PMID: 10805874BACKGROUND

  • Cambria RP, Davison JK, Carter C, Brewster DC, Chang Y, Clark KA, Atamian S. Epidural cooling for spinal cord protection during thoracoabdominal aneurysm repair: A five-year experience. J Vasc Surg. 2000 Jun;31(6):1093-102. doi: 10.1067/mva.2000.106492.

    PMID: 10842145BACKGROUND

  • Walker SR, Yusuf SW, Wenham PW, Hopkinson BR. Renal complications following endovascular repair of abdominal aortic aneurysms. J Endovasc Surg. 1998 Nov;5(4):318-22. doi: 10.1583/1074-6218(1998)0052.0.CO;2.

    PMID: 9867320BACKGROUND

  • Thompson JP, Boyle JR, Thompson MM, Strupish J, Bell PR, Smith G. Cardiovascular and catecholamine responses during endovascular and conventional abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 1999 Apr;17(4):326-33. doi: 10.1053/ejvs.1998.0760.

    PMID: 10204055BACKGROUND

  • Zarins CK, White RA, Schwarten D, Kinney E, Diethrich EB, Hodgson KJ, Fogarty TJ. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg. 1999 Feb;29(2):292-305; discussion 306-8. doi: 10.1016/s0741-5214(99)70382-4.

    PMID: 9950987BACKGROUND

  • May J, White GH, Yu W, Ly CN, Waugh R, Stephen MS, Arulchelvam M, Harris JP. Concurrent comparison of endoluminal versus open repair in the treatment of abdominal aortic aneurysms: analysis of 303 patients by life table method. J Vasc Surg. 1998 Feb;27(2):213-20; discussion 220-1. doi: 10.1016/s0741-5214(98)70352-0.

    PMID: 9510276BACKGROUND

  • Chuter TA, Reilly LM, Faruqi RM, Kerlan RB, Sawhney R, Canto CJ, LaBerge JM, Wilson MW, Gordon RL, Wall SD, Rapp J, Messina LM. Endovascular aneurysm repair in high-risk patients. J Vasc Surg. 2000 Jan;31(1 Pt 1):122-33. doi: 10.1016/s0741-5214(00)70074-7.

    PMID: 10642715BACKGROUND

  • Mitchell RS, Miller DC, Dake MD, Semba CP, Moore KA, Sakai T. Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation". Ann Thorac Surg. 1999 Jun;67(6):1971-4; discussion 1979-80. doi: 10.1016/s0003-4975(99)00436-1.

    PMID: 10391350BACKGROUND

  • Kinney EV, Kaebnick HW, Mitchell RA, Jung MT. Repair of mycotic paravisceral aneurysm with a fenestrated stent-graft. J Endovasc Ther. 2000 Jun;7(3):192-7. doi: 10.1177/152660280000700304.

    PMID: 10883955BACKGROUND

  • Iwase T, Inoue K, Sato M, Yoshida Y, Ueno K, Tanaka H, Tamaki S. Transluminal repair of an infrarenal aortoiliac aneurysm by a combination of bifurcated and branched stent grafts. Catheter Cardiovasc Interv. 1999 Aug;47(4):491-4. doi: 10.1002/(SICI)1522-726X(199908)47:43.0.CO;2-I.

    PMID: 10470482BACKGROUND

  • Chuter TA, Gordon RL, Reilly LM, Goodman JD, Messina LM. An endovascular system for thoracoabdominal aortic aneurysm repair. J Endovasc Ther. 2001 Feb;8(1):25-33. doi: 10.1177/152660280100800104.

    PMID: 11220464BACKGROUND

  • Anderson JL, Berce M, Hartley DE. Endoluminal aortic grafting with renal and superior mesenteric artery incorporation by graft fenestration. J Endovasc Ther. 2001 Feb;8(1):3-15. doi: 10.1177/152660280100800102.

    PMID: 11220465BACKGROUND

  • Chuter TA, Buck DG, Schneider DB, Reilly LM, Messina LM. Development of a branched stent-graft for endovascular repair of aortic arch aneurysms. J Endovasc Ther. 2003 Oct;10(5):940-5. doi: 10.1177/152660280301000517.

    PMID: 14656176BACKGROUND

  • Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.

    PMID: 17980540BACKGROUND

  • Chuter TA, Hiramoto JS, Park KH, Reilly LM. The transition from custom-made to standardized multibranched thoracoabdominal aortic stent grafts. J Vasc Surg. 2011 Sep;54(3):660-7; discussion 667-8. doi: 10.1016/j.jvs.2011.03.005. Epub 2011 Jul 23.

    PMID: 21788114BACKGROUND

  • Chuter T, Greenberg RK. Standardized off-the-shelf components for multibranched endovascular repair of thoracoabdominal aortic aneurysms. Perspect Vasc Surg Endovasc Ther. 2011 Sep;23(3):195-201. doi: 10.1177/1531003511430397.

    PMID: 22205654BACKGROUND

  • 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.

    PMID: 22560233BACKGROUND

  • 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.

    PMID: 23395201BACKGROUND

  • Premprabha D, Sobel J, Pua C, Chong K, Reilly LM, Chuter TA, Hiramoto JS. Visceral branch occlusion following aneurysm repair using multibranched thoracoabdominal stent-grafts. J Endovasc Ther. 2014 Dec;21(6):783-90. doi: 10.1583/14-4807R.1.

    PMID: 25453879BACKGROUND

  • 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.

    PMID: 25457458BACKGROUND

  • 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.

    PMID: 26817612BACKGROUND

  • 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.

    PMID: 26994953BACKGROUND

  • Mesnard T, Huang Y, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zetterval SL, Lee A, Oderich GS; United States Aortic Research Consortium. Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-Branched Endovascular Aortic Repair: A Ten-year Experience. Ann Surg. 2025 Feb 18. doi: 10.1097/SLA.0000000000006676. Online ahead of print.

    PMID: 39963789DERIVED

  • Oderich GS, Huang Y, Harmsen WS, Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Gasper WJ, Beck AW, Sweet MP, Lee WA; United States Aortic Research Consortium. Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study. Circulation. 2024 Oct 22;150(17):1343-1353. doi: 10.1161/CIRCULATIONAHA.123.068234. Epub 2024 Jul 11.

    PMID: 38989575DERIVED

  • Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16.

    PMID: 37330702DERIVED

  • Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium. J Vasc Surg. 2023 Jun;77(6):1578-1587. doi: 10.1016/j.jvs.2023.01.205. Epub 2023 Apr 13.

    PMID: 37059239DERIVED

  • Werlin EC, Kaushik S, Gasper WJ, Hoffman M, Reilly LM, Chuter TA, Hiramoto JS. Multibranched endovascular aortic aneurysm repair in patients with and without chronic aortic dissections. J Vasc Surg. 2019 Nov;70(5):1419-1426. doi: 10.1016/j.jvs.2019.02.048. Epub 2019 Jul 18.

    PMID: 31327618DERIVED

  • Walker J, Kaushik S, Hoffman M, Gasper W, Hiramoto J, Reilly L, Chuter T. Long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms. J Vasc Surg. 2019 Feb;69(2):341-347. doi: 10.1016/j.jvs.2018.04.074.

    PMID: 30683193DERIVED

  • Chang CK, Chuter TA, Niemann CU, Shlipak MG, Cohen MJ, Reilly LM, Hiramoto JS. Systemic inflammation, coagulopathy, and acute renal insufficiency following endovascular thoracoabdominal aortic aneurysm repair. J Vasc Surg. 2009 May;49(5):1140-6. doi: 10.1016/j.jvs.2008.11.102.

    PMID: 19394543DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, ThoracoabdominalAneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, AbdominalAortic AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Warren J Gasper, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren J Gasper, MD

CONTACT

415 750 2115warren.gasper@ucsf.edu

Madeleine L Clinch

CONTACT

415-353-4367Madeleine.Clinch@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Surgery

Study Record Dates

First Submitted

June 5, 2007

First Posted

June 6, 2007

Study Start

May 1, 2005

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(2)