ClinicalTrials.gg
RecruitingNCT00483249Updated Nov 10, 2026

Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

An interventional study of Endovascular Branched Stent-Graft in Thoracoabdominal Aortic Aneurysm and Paravisceral Abdominal Aortic Aneurysm, sponsored by Warren J. Gasper, MD. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Warren J. Gasper, MD · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thoracoabdominal Aortic Aneurysm
  • Paravisceral Abdominal Aortic Aneurysm

Keywords

  • Thoracoabdominal
  • Paravisceral
  • Aneurysm
  • Endovascular
  • Stent-Graft
  • Aorta
03

In context

Aortic Aneurysm, Thoracoabdominal

63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.

This study's planned enrollment of 250 is above the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.

Browse Aortic Aneurysm, Thoracoabdominal studies →

Lead sponsor

This is the only study on the registry with Warren J. Gasper, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. more than 2 years.
  4. Ability to give .
  5. Willingness to comply with follow-up schedule.
  6. Suitable arterial anatomy for endovascular repair.

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceEndovascular Branched Stent-Graft

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

06

What researchers measure

Primary outcomes

  1. Successful implantation of TAAA branched stent-graft.

    Time frame: 1 month

Secondary outcomes

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

    Time frame: 5 years

07

Study locations

2 of 2 sites recruiting
  • Division of Vascular Surgery, SFVAMC
    San Francisco, California 94121, United States
    Recruiting
    • Warren J Gasper, MD · Principal investigator
    • Linda M Reilly, MD · Sub investigator
  • Division of Vascular Surgery, UCSF
    San Francisco, California 94143, United States
    Recruiting
    • Linda M Reilly, MD · Sub investigator
    • Warren J Gasper, MD · Principal investigator
    • Timothy AM Chuter, MD · Sub investigator
    • Jade S Hiramoto, MD · Sub investigator
    • Shant M Vartanian, MD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 3959256 ↗
  • 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. PubMed 8433431 ↗
  • 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. PubMed 10805874 ↗
  • 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. PubMed 10842145 ↗
  • 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. PubMed 9867320 ↗
  • 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. PubMed 10204055 ↗
  • 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. PubMed 9950987 ↗
  • 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. PubMed 9510276 ↗
  • 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. PubMed 10642715 ↗
  • 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. PubMed 10391350 ↗
  • 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. PubMed 10883955 ↗
  • 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. PubMed 10470482 ↗
  • 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. PubMed 11220464 ↗
  • 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. PubMed 11220465 ↗
  • 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. PubMed 14656176 ↗
  • 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. PubMed 17980540 ↗
  • 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. PubMed 21788114 ↗
  • 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. PubMed 22205654 ↗
  • 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. PubMed 22560233 ↗
  • 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. PubMed 23395201 ↗
  • 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. PubMed 25453879 ↗
  • 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. PubMed 25457458 ↗
  • 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. PubMed 26817612 ↗
  • 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. PubMed 26994953 ↗
  • 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. 2026 Jul 1;284(1):184-193. doi: 10.1097/SLA.0000000000006676. Epub 2025 Feb 18. PubMed 39963789 ↗
  • 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. PubMed 38989575 ↗
  • 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. PubMed 37330702 ↗
  • 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. PubMed 37059239 ↗
  • 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. PubMed 31327618 ↗
  • 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. PubMed 30683193 ↗
  • 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. PubMed 19394543 ↗
09

Timeline

1 registry update since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimatedDate before it movedWhere the date was before it moved

The record gives a start of May 2005, a primary completion of Dec 2028 and a completion of Dec 2028. It does not say whether these dates are actual or estimated.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Dec 2027 → Dec 2028 and completion Dec 2027 → Dec 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2007
First posted
Jun 6, 2007
Start
May 2005
Primary completionEst.
Dec 2028was Dec 2027
CompletionEst.
Dec 2028was Dec 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Dec 2027→Dec 2028
Nov 10, 2026
Study completion
Dec 2027→Dec 2028
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Primary completion Dec 2027→Dec 2028
    Study completion Dec 2027→Dec 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00483249
Lead sponsor
Warren J. Gasper, MD
Responsible party
Warren J. Gasper, MD (Associate Professor, Surgery, University of California, San Francisco) — Sponsor-investigator
First posted
Jun 6, 2007
Start date
May 2005
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Warren J Gasper, MD
Contact
warren.gasper@ucsf.edu
415 750 2115
Madeleine L Clinch
Contact
Madeleine.Clinch@ucsf.edu
415-353-4367
Warren J Gasper, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion