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TBE Zone 0/1 PMS in Japan

NCT07691931 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-07-09

No results posted yet for this study

Summary

The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.

Conditions

  • Aneurysm of Aorta, Thoracic
  • Dissection of Aorta, Thoracic
  • Trauma

Interventions

DEVICE

Gore® TAG® Thoracic Aortic Branch Stent Graft System

Patients who attempted implant of TBE in Zone 0/1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0/1 area).

Sponsors & Collaborators

  • CMIC Co, Ltd. Japan

    collaborator INDUSTRY

  • W.L.Gore & Associates

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2035-09-30
Completion
2035-09-30
FDA Device
Yes

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Entities

Diseases

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 NCT07691931 on ClinicalTrials.gov