An interventional study of B-TEVAR device in Thoracoabdominal Aortic Aneurysm, Without Rupture, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 290 is above the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following:
A. Non-aneurysmal proximal aortic seal zone:
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:
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 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
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of the B-TEVAR device
Device: B-TEVAR device
Implantation of the Branched Thorcoabdominal aortic anerysm device
The effectiveness of multi-branched endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success
Time frame: 12 months post-procedure.
Mortality rates
Time frame: 12 months
Technical Success
Technical Success is defined as successful delivery and deployment of the physician modified graft with preservation of unimpeded flow to those branch vessels intended to be preserved.
Time frame: 12 months
Plan to share: Yes — Deidentified data are shared with the Aortic Research Consortium research group
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Aortic Aneurysm, Thoracoabdominal →