TAMBE device post-marketing safety and effectiveness for thoracoabdominal and pararenal aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who were attempted to implant the AC
* Thoracoabdominal aortic aneurysm
* Pararenal abdominal aortic aneurysm

Exclusion Criteria:

* N/A

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.