TAMBE device post-marketing safety and effectiveness for thoracoabdominal and pararenal aortic aneurysms
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance
This tests whether the TAMBE multi-component device (GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis) is safe and works well for people treated for thoracoabdominal or pararenal aortic aneurysms in Japan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | W.L.Gore & Associates Industry-sponsored |
| Locations | 5 sites (Minatoku and 4 other locations) |
| Trial ID | NCT07147569 on ClinicalTrials.gov |
What this trial studies
This is an observational post-marketing surveillance program following patients in Japan who had an attempt to implant the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (Aortic Component, AC) for thoracoabdominal or pararenal abdominal aortic aneurysms. Participating centers collect real-world data on procedural details, device performance, adverse events, reinterventions, and imaging findings during routine follow-up. Data are reported to the sponsor to characterize safety signals and clinical outcomes in typical practice settings. The program aims to inform clinicians and regulators about device performance outside premarket trials.
Who should consider this trial
Good fit: Ideal candidates are adults in Japan with thoracoabdominal or pararenal aortic aneurysms who underwent an attempted implant of the AC component at a participating site.
Not a fit: Patients who were not offered or did not undergo an attempted AC implant, or whose anatomy or health status make branched endografting inappropriate, are unlikely to receive benefit from this program.
Why it matters
Potential benefit: If successful, this could confirm that the TAMBE device is a durable endovascular option for complex aortic aneurysms and improve confidence in patient safety and treatment planning.
How similar studies have performed: Branched and fenestrated aortic endografts have shown promising outcomes in prior clinical experience, but specific post-marketing evidence for this TAMBE configuration remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who were attempted to implant the AC * Thoracoabdominal aortic aneurysm * Pararenal abdominal aortic aneurysm Exclusion Criteria: * N/A
Where this trial is running
Minatoku and 4 other locations
- The Jikei University Hospital — Minatoku, Japan (Recruiting)
- Nagoya University Hospital — Nagoya, Japan (Recruiting)
- Morinomiya Hospital — Osaka, Japan (Recruiting)
- Osaka International Medical & Science Center Osaka Police Hospital — Osaka, Japan (Recruiting)
- The University of Osaka Hospital — Suita, Japan (Recruiting)
Study contacts
- Study coordinator: Katsuyuki Niwa
- Email: kniwa@wlgore.com
- Phone: +819017754499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.