TBE Zone 2 PMS in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2034-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Aneurysm Thoracic Dissection of Aorta, Thoracic Trauma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TBE

Gore® TAG® Thoracic Aortic Branch Stent Graft System

Intervention Type DEVICE

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

Interventions

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Gore® TAG® Thoracic Aortic Branch Stent Graft System

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Those who are suitable for use of TBE according to the Japan package insert.

\[Reference: Purpose of Use or Effects of TBE at the time of launch\] The GORE TAG Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases with descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to the left subclavian artery.

* Thoracic aortic aneurysm,
* Traumatic transection, and
* Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy.