Real-world check for GORE TAMBE device in tough aortic aneurysms
NCT ID NCT06578741
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study follows 300 people who received the GORE TAMBE device to treat complex aortic aneurysms. The goal is to confirm the device works safely and effectively outside of clinical trials. Researchers will track technical success and patient outcomes over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) – a stent graft device
- What this could lead to
- If successful, this study confirms the device is safe and effective for treating complex aortic aneurysms in everyday practice.
- What could go wrong
- This is a post-approval study, not a new treatment test. It mainly monitors real-world outcomes, so no major breakthroughs are expected. Risks include device complications like leaks or blockages.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
310 people
The number who actually took part.
- Started
-
Nov 2024
- Expected to finish
-
Jun 2036
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The subject is / has: 1. Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels. 2. Age ≥18 years at the time of informed consent signature. 3. An Informed Consent Form signed by subject or legal representative. Exclusion Criteria: The subject is / has: 1. Any contraindications for the TAMBE Device according to the IFU. 2. Planned parallel grafting with the TAMBE Aortic Component. 3. Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Abdominal aortic aneurysm are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Stanford Hospital
Stanford, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stent graft tested for keeping kidney and gut arteries open during aneurysm repair
- Can a tailored stent graft tame complex aortic aneurysms?
- Can sound waves replace CT scans for aortic aneurysm monitoring?
- A simple gas flush before aortic repair might prevent strokes
- Can a stent-graft keep aortic aneurysms in check for years? a long-term follow-up study aims to find out.
- Aneurysm repair may stiffen arteries — a study asks what that means for the heart