RecruitingNCT07049913

TBE Zone 2 PMS in Japan

GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance in Japan


Sponsor

W.L.Gore & Associates

Enrollment

200 participants

Start Date

Dec 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This post-market surveillance study in Japan tracks how a device called the GORE TAG Thoracic Branch Endoprosthesis (TBE) performs in real-world clinical use. The TBE is a stent-graft placed inside the aorta (the body's main artery) to treat certain diseases of the descending thoracic aorta while keeping blood flowing to the left subclavian artery (which supplies the left arm). **You may be eligible if:** - Your doctor has determined that you are suitable for the TBE device based on the Japanese product label - You have a thoracic aortic aneurysm (a bulge in the chest aorta), a traumatic tear in the aorta, or a complicated type B aortic dissection that has not responded to medication - Your anatomy meets the device's technical requirements **You may NOT be eligible if:** - Your doctor has determined that you do not meet the device's approved indications or anatomical criteria (there are no specific listed exclusion criteria — eligibility is determined by your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGore® TAG® Thoracic Aortic Branch Stent Graft System

Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.


Locations(1)

The University of Osaka Hospital

Osaka, Suita, Japan

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NCT07049913


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