Thoracoabdominal Aortic Aneurysm, Without RuptureB-TEVARNCT01874197
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
A study testing B-TEVAR device in people with Thoracoabdominal Aortic Aneurysm, Without Rupture, run by University of Washington at 1 site in United States.
Trial summary
An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Without Rupture
- What is being tested?
- B-TEVAR device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
- Patient is > 18 years of age
- Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study.
- Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
- Patient is considered by the treating physician and a second attending physician experienced in the care of patients with aneurysmal disease to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD, CHF, COPD, CRI, advanced age, generalized deconditioning, or other.) with ASA of 3 or more.
- The patient has reasonable expectation of surviving the B-TEVAR procedure and has a life expectancy of greater than 1 year as determined by the PI and a second attending physician experienced in the care of patients with aneurysmal disease.
Show all 32Show fewer
- The patient has a thoraco-abdominal aortic aneurysm where necessary visceral branch vessels (i.e. the celiac, superior mesenteric, inferior mesenteric, renal and/or dominant spinal arteries) arise from the aneurysm or seal zones necessary for on-label thoracic endovascular repair
- Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following:
- aneurysm > 5.5 cm in diameter
- aneurysm has increased in size by 0.5 cm in last 6 months
- aneurysm is believed to be causing symptoms
- Patient has sufficient arterial access (femoral and/or iliac) that will allow delivery of the endovascular device with or without the use of a surgical conduit.
- Patient has suitable proximal (aorta) and distal (aorta or iliac) arteries to allow for adequate fixation and seal:
- Non-aneurysmal proximal aortic seal zone:
- Standard BTEVAR cohort will require a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery.
- The BTEVAR-CTD cohort will require a length of 30 mm of proximal seal with an outer wall diameter of no less than 15 mm and no greater than 42 mm, and
- B. Non-aneurysmal distal aortic or iliac landing zone:
- With a length of at least 15 mm,
- Aortic seal zone no less than 15 mm and no greater than 42 mm or
- Iliac seal zone with an outer wall diameter of no less than 8 mm and no greater than 23 mm.
- 10. The patient has no more than 5 necessary visceral arteries that require flow preservation.
- 11. All target visceral artery seal zones are > 4 mm in diameter. 12. Patient must be willing to comply with all required follow-up exams.
- 5.1.2 Exclusion Criteria
- Patients that meet ANY of the following are not eligible for enrollment into the study:
- Patient has an active systemic infection
- Patient has a mycotic aneurysm.
- Patient has a known hypersensitivity to contrast media that is not amenable to pre- treatment.
- Patient has an absolute contra-indication to anticoagulation
- Patient has known sensitivities or allergies to nitinol (nickel, titanium), polyester, polypropylene, gold,
- 1. stainless steel, or solder (tin, silver) 6. Patient has a body habitus that would inhibit adequate X-ray visualization of the aorta 7. Patient has a dominant artery to the spinal cord arising from an area of stent graft coverage that is not amenable to preservation using an endovascular branch 8. Patient is currently participating in another investigational device or drug clinical trial 9. Patient is suitable, in the opinion of the investigator, for treatment in accordance with the instructions for use with a legally marketed endovascular prosthesis 10. Patient is suitable, in the opinion of the investigator, for treatment and eligible for enrollment in a manufacturer-sponsored IDE at the investigational site 11. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
- 12. Patient has a freely ruptured TAAA with hemodynamic instability 13. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) 14. Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned within 30 days of the TAAA repair. Adjunctive procedures for treatment of the TAAA (i.e. carotid-subclavian bypass or iliac conduit) are acceptable.
- 15. Patient has a history of an aortopathic connective tissue disease (e.g. Marfan or Ehlers Danlos syndromes) (This exclusion criteria will not apply for the BTEVAR-CTD substudy cohort) 16. Illicit drug use within the last 12 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
Matthew Sweet, MD
BTEVAR@uw.edu
About this study
Official title: Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: An Investigator-Initiated Study
An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical.
The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.
Read the detailed description
A branched thoracic endograft is a commercially manufactured endograft that has reinforced fenestrations or branches in the graft through which covered stent grafts can be deployed to preserve blood flow into visceral branch vessels.
The branched stent graft is deployed to reline the peri-visceral abdominal aorta. Proximal and distal fixation and seal can be achieved using the branched device, additional Cook Alpha Thoracic devices and/or the Cook Zenith® Flex® device depending on the aortic anatomy.
Once the aortic stent grafts are deployed, the branches are then created. Wires and catheters are used to cross through the reinforced fenestrations into the target visceral arteries. Covered stents are then deployed to extend from the modified aortic graft to the target vessel. The branch stents must create a hemostatic seal with the main endograft as these branches will be constructed within the aneurysm sac. Single or multiple stents may be required for any given branch.
- Being tested
- B-TEVAR device
- Keywords
- Thoracoabdominal Aortic Aneurysm, Branched vessels
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-TEVAR deviceDevice
Implantation of the Branched Thorcoabdominal aortic anerysm device
| Study group | Role | What they receive |
|---|---|---|
| B -TEVAR | Other | Implantation of the B-TEVAR device Receives: Device: B-TEVAR device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of multi-branched endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success
Measured: 12 months post-procedure.
Secondary outcomes (1)
Mortality rates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal Aortic Aneurysm, Without RuptureStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Sweet, University of Washington
- Investigators
- Matthew P Sweet, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874197
- Sponsor's protocol ID
- STUDY00004379
- Acronym
- B-TEVAR
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2013
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data are shared with the Aortic Research Consortium research group
Publications
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 37059239Chamseddin K, Timaran CH, Oderich GS, Tenorio ER, Farber MA, Parodi FE, Schneider DB, Schanzer A, Beck AW, Sweet MP, Zettervall SL, Mendes B, Eagleton MJ, Gasper WJ; U.S. Aortic Research Consortium. Comparison of upper extremity and transfemoral access for fenestrated-branched endovascular aortic repair. J Vasc Surg. 2023 Mar;77(3):704-711. doi: 10.1016/j.jvs.2022.10.009. Epub 2022 Oct 17.
PubMed 36257344Zettervall SL, Tenorio ER, Schanzer A, Oderich GS, Timaran CH, Schneider DB, Eagleton M, Farber MA, Gasper WJ, Beck AW, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium. Secondary interventions after fenestrated/branched aneurysm repairs are common and nondetrimental to long-term survival. J Vasc Surg. 2022 May;75(5):1530-1538.e4. doi: 10.1016/j.jvs.2021.11.074. Epub 2021 Dec 23.
PubMed 34954272Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zettervall SL, Huang Y, Oderich GS; U.S. Fenestrated and Branched Aortic Research Consortium. Effect of bridging stent graft selection for directional branches on target artery outcomes of fenestrated-branched endovascular aortic repair in the United States Aortic Research Consortium. J Vasc Surg. 2023 Jul;78(1):10-28.e3. doi: 10.1016/j.jvs.2023.03.025. Epub 2023 Mar 21.
PubMed 36948277Pujari A, Ahmad M, Sweet MP, Zettervall SL. Overhead arm support reduces radiation exposure during complex endovascular aortic repair. J Vasc Surg. 2023 Apr;77(4):991-996. doi: 10.1016/j.jvs.2022.12.021. Epub 2022 Dec 21.
PubMed 36565780Edman NI, Schanzer A, Crawford A, Oderich GS, Farber MA, Schneider DB, Timaran CH, Beck AW, Eagleton M, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium. Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium. J Vasc Surg. 2021 Sep;74(3):861-870. doi: 10.1016/j.jvs.2021.02.046. Epub 2021 Mar 26.
PubMed 33775747Sweet MP, Starnes BW, Tatum B. Endovascular treatment of thoracoabdominal aortic aneurysm using physician-modified endografts. J Vasc Surg. 2015 Nov;62(5):1160-7. doi: 10.1016/j.jvs.2015.05.036. Epub 2015 Jul 17.
PubMed 26194816Timaran CH, Oderich GS, Tenorio ER, Farber MA, Schneider DB, Schanzer A, Beck AW, Sweet MP; Aortic Research Consortium. Expanded Use of Preloaded Branched and Fenestrated Endografts for Endovascular Repair of Complex Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):219-226. doi: 10.1016/j.ejvs.2020.11.001. Epub 2020 Nov 28.
PubMed 33262091Schanzer A, Beck AW, Eagleton M, Farber MA, Oderich G, Schneider D, Sweet MP, Crawford A, Timaran C; U.S. Multicenter Fenestrated/Branched Aortic Research Consortium. Results of fenestrated and branched endovascular aortic aneurysm repair after failed infrarenal endovascular aortic aneurysm repair. J Vasc Surg. 2020 Sep;72(3):849-858. doi: 10.1016/j.jvs.2019.11.026. Epub 2020 Mar 3.
PubMed 32144014Chen S, Ramirez E, Murphy BE, Sribalaskandarajah A, Bunker M, Kruger J, Newhall KA, Sorber RA, Zettervall SL, Sweet MP. Increased clinical frailty is associated with aortic-related mortality following fenestrated and branched endovascular repair for thoracoabdominal aortic aneurysm. J Vasc Surg. 2026 Mar;83(3):688-698. doi: 10.1016/j.jvs.2025.10.011. Epub 2025 Oct 14.
PubMed 41101709Murphy BE, Bunker M, Gillan A, Sorber R, Zettervall SL, Sweet MP. Clinical frailty predicts long-term survival and return to functional status following fenestrated and branched aortic repair for thoracoabdominal aortic aneurysm. J Vasc Surg. 2025 Jul;82(1):62-71. doi: 10.1016/j.jvs.2025.03.058. Epub 2025 Mar 12.
PubMed 40086494Mesnard 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 39963789Oderich 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 38989575Finnesgard 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