TBE Zone 2 PMS in Japan
NCT07049913 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-02-05
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.
Conditions
- Aneurysm Thoracic
- Dissection of Aorta, Thoracic
- Trauma
Interventions
- DEVICE
-
Gore® TAG® Thoracic Aortic Branch Stent Graft System
Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.
Sponsors & Collaborators
-
CMIC Co, Ltd. Japan
collaborator INDUSTRY -
W.L.Gore & Associates
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-15
- Primary Completion
- 2034-02-28
- Completion
- 2034-02-28
- FDA Device
- Yes
Countries
- Japan
Study Locations
More Related Trials
-
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
NCT00608829 ·Status: COMPLETED ·Phase: PHASE2
-
Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
NCT02021812 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
NCT05442489 ·Status: APPROVED_FOR_MARKETING
-
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
NCT00874250 ·Status: COMPLETED ·Phase: NA
-
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
NCT06578741 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
NCT00908388 ·Status: COMPLETED ·Phase: NA
-
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
NCT06507865 ·Status: RECRUITING
-
Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
NCT00917852 ·Status: COMPLETED ·Phase: NA
-
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
NCT00757003 ·Status: COMPLETED ·Phase: PHASE3
-
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
NCT02528500 ·Status: COMPLETED ·Phase: NA
-
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
NCT02266342 ·Status: COMPLETED
-
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
NCT06658730 ·Status: RECRUITING
-
Evaluation of the GORE® Ascending Stent Graft
NCT05800743 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection
NCT00742274 ·Status: COMPLETED ·Phase: NA
-
Safety, Efficacy and Cost Analysis of the Conformable Thoracic Stent Graft With ACTIVE CONTROL
NCT04452240 ·Status: UNKNOWN
-
REgistRy BRAnch goRE EndopRosthEsis
NCT06276413 ·Status: NOT_YET_RECRUITING
-
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
NCT06827990 ·Status: RECRUITING ·Phase: NA
-
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
NCT03286400 ·Status: COMPLETED
-
Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
NCT05639569 ·Status: RECRUITING
-
Thoracoabdominal Artery Stent Graft System Exploratory Study
NCT06710938 ·Status: RECRUITING ·Phase: NA
-
Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
NCT05430672 ·Status: UNKNOWN ·Phase: NA
-
ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
NCT02380716 ·Status: COMPLETED
-
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
NCT00805948 ·Status: TERMINATED ·Phase: NA
-
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
NCT03207568 ·Status: COMPLETED ·Phase: NA
-
Real-world Study on Fenestrated Stent for Thoracic Aortic Dissection
NCT07268755 ·Status: ACTIVE_NOT_RECRUITING