TBE Zone 0/1 PMS in Japan

Starting soon

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

In brief

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.

Key facts

Study ID

NCT07691931

Run by

W.L.Gore & Associates

People needed

75

Starts

2026-09-01

Expected to finish

2035-09-01

Last updated by the study team

2026-07-09

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 of the aortic arch and descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to a single aortic arch target branch vessel.
• Thoracic aortic aneurysm
• Traumatic transection
• Complicated Stanford type A (after surgical repair) and B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy
• The GORE® TAG® Thoracic Branch Endoprosthesis may be used in combination with designated stent grafts with validated efficacy and safety.

You may not qualify if…

• N/A

Full record on ClinicalTrials.gov

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