TBE stent-graft repair for thoracic aortic disease with Zone 2 proximal landing in Japan

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

This project will try the GORE TAG Thoracic Branch stent graft in people in Japan who need repair of descending thoracic aortic aneurysm, traumatic transection, or complicated type B dissection with a proximal landing in Zone 2.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: W.L.Gore & Associates (industry)
• Locations: 1 site (Osaka, Suita)
• Trial ID: NCT07049913 on ClinicalTrials.gov

What this trial studies

This is a post-marketing observational surveillance using the GORE TAG Thoracic Branch Stent Graft System to confirm safety and effectiveness when the device is landed proximally in aortic Zone 2. Patients are enrolled if they meet the Japan package insert anatomical requirements for preserving left subclavian artery blood flow, including thoracic aortic aneurysm, traumatic transection, or complicated Stanford type B dissection not controlled by medical therapy. Treatments follow routine clinical care at participating centers and outcomes and adverse events are collected during follow-up. The registry-style design is non-randomized and intended to capture real-world device performance in the post-marketing period.

Who should consider this trial

Good fit: Ideal candidates are patients in Japan with descending thoracic aortic lesions who meet the Japan package insert anatomical criteria and have thoracic aortic aneurysm, traumatic transection, or complicated type B dissection not controlled by medical therapy.

Not a fit: Patients who do not meet the device's anatomical requirements or whose conditions can be managed without endovascular repair are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could support a treatment option that repairs descending thoracic aortic lesions while preserving flow to the left subclavian artery.

How similar studies have performed: Prior observational series of GORE thoracic branch and other branched endografts have shown promising outcomes, but use specifically landing in Zone 2 is relatively recent and evidence remains limited.

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

Where this trial is running

Osaka, Suita

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

Study contacts

• Study coordinator: Hideyuki Saigusa

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