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TAMBE Japan Post-Marketing Surveillance

NCT07147569 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-05

No results posted yet for this study

Summary

To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.

Conditions

  • Thoracoabdominal Aortic Aneurysm
  • Pararenal Aortic Aneurysm

Interventions

DEVICE

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.

Sponsors & Collaborators

  • CMIC Co, Ltd. Japan

    collaborator INDUSTRY

  • W.L.Gore & Associates

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2034-02-28
Completion
2034-02-28
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147569 on ClinicalTrials.gov