TBE Zone 2 PMS in Japan

Recruiting now

Conditions studied: Aneurysm Thoracic, Dissection of Aorta, Thoracic, Trauma

In brief

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.

Key facts

Study ID

NCT07049913

Run by

W.L.Gore & Associates

People needed

200

Starts

2025-12-15

Expected to finish

2034-02-01

Last updated by the study team

2026-02-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• N/A

Where it is running

• The University of Osaka Hospital — Osaka, Suita, Japan (enrolling)

Full record on ClinicalTrials.gov

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