RecruitingNCT07049913
TBE Zone 2 PMS in Japan
GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance in Japan
Sponsor
W.L.Gore & Associates
Enrollment
200 participants
Start Date
Dec 15, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria1
- N/A
Interventions
DEVICEGore® TAG® Thoracic Aortic Branch Stent Graft System
Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07049913
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