TBE Zone 2 PMS in Japan

Launched by W.L.GORE & ASSOCIATES · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medical device called the TBE, which is used to treat certain serious problems in the large blood vessel that runs through the chest (the thoracic aorta). These problems include bulges in the artery wall (aneurysms), tears in the artery (dissections), and injuries caused by trauma. The TBE device helps repair these issues while making sure blood flow to an important artery near the shoulder (the left subclavian artery) is maintained. The study will look at patients who have been treated with the TBE device in a specific area of the aorta called Zone 2, after the device has already been approved and is in regular use.

People who might be eligible to join this study are those who have one of these aortic conditions and meet certain anatomical requirements, meaning their blood vessels are suitable for the device. This includes patients with thoracic aortic aneurysms, traumatic tears in the aorta, or complicated type B aortic dissections that have not improved with standard medical treatments. The study is open to adults of any gender, but it is not yet recruiting participants. If you join, doctors will monitor your health to confirm the device works well and is safe when used in real-world settings. This information helps ensure the treatment continues to be effective and safe for patients like you.

Gender

ALL

Eligibility criteria

• 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.
• Exclusion Criteria:
• • N/A