TBE Zone 2 PMS in Japan

W.L. Gore & Associates

Status: Begins enrollment this month

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

Treatments: Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System

Study type: Observational

Funder types: Industry

Identifiers

NCT07049913

JPS 25-01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

TBE

Treatment:

Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System