Thoracoabdominal AneurysmTAMBENCT05442489
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
A study testing GORE Excluder Thoracoabdominal Branch Endoprosthesis in people with Thoracoabdominal Aneurysm, run by W.L.Gore & Associates at 41 sites in United States.
Trial summary
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thoracoabdominal Aneurysm
- What is being tested?
- GORE Excluder Thoracoabdominal Branch Endoprosthesis
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 41 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Adult, Older adult
- Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (≥ 5 mm in one year)
- An Informed Consent Form signed by Subject or legal representative
- Appropriate aortic anatomy to receive the TAMBE Device d
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
University of Michigan - Cardiac Surgery
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
St. David's Healthcare
Austin, Texas, 78705
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
University of Texas Southwestern
Dallas, Texas, 75352
Essentia Health
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida - Gainesville
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
The Methodist Hospital - Houston
Houston, Texas, 77030
University of Texas Health Science Center
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46226
University of Tennessee -University Vascular Surgeons
Knoxville, Tennessee, 37920
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Keck Medical Center of USC
Los Angeles, California, 90033
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, 53215
Division of Vascular Surgery - Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Mount Sinai West
New York, New York, 10019
Weill Cornell Medical Center
New York, New York, 10065
Sentara Medical Group
Norfolk, Virginia, 23507
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UPP Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15213
Carilion Clinic Hospitals
Roanoke, Virginia, 24014
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14627
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94118
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
University of Washington
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
University of South Florida
Tampa, Florida, 33606
MedStar Health Research Institute - MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
Read the detailed description
Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.
- Conditions
- Thoracoabdominal Aneurysm
- Being tested
- GORE Excluder Thoracoabdominal Branch Endoprosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE Excluder Thoracoabdominal Branch EndoprosthesisDevice
Also called TAMBE
TEVAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal AneurysmStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442489
- Sponsor's protocol ID
- AAA 17-01 Expanded Access
- Acronym
- TAMBE
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2022
- Last updated
- 18 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
- ClinicalTrials.gov ID
- NCT05442489
- Acronym / sponsor ID
- TAMBE / AAA 17-01 Expanded Access
- Conditions
- Thoracoabdominal Aneurysm
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
Detailed description
Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.
Study design
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GORE Excluder Thoracoabdominal Branch EndoprosthesisAlso: TAMBETEVAR | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE Excluder Thoracoabdominal Branch Endoprosthesis in people with Thoracoabdominal Aneurysm, run by W.L.Gore & Associates at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.