Actively Recruiting

All Genders
NCT07049913

TBE Zone 2 PMS in Japan

Led by W.L.Gore & Associates · Updated on 2026-02-05

200

Participants Needed

1

Research Sites

424 weeks

Total Duration

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Sponsors

W

W.L.Gore & Associates

Lead Sponsor

C

CMIC Co, Ltd. Japan

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.

CONDITIONS

Official Title

TBE Zone 2 PMS in Japan

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suitable for use of the Gore TAG Thoracic Branch Endoprosthesis according to Japan package insert
  • Diagnosis of thoracic aortic aneurysm
  • Diagnosis of traumatic transection involving the thoracic aorta
  • Diagnosis of complicated Stanford type B aortic dissection not responding to medical therapy
  • Anatomical suitability to preserve blood flow to the left subclavian artery during treatment
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Osaka Hospital

Osaka, Suita, Japan, 565-0871

Actively Recruiting

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Research Team

H

Hideyuki Saigusa

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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