Trials / Recruiting
RecruitingNCT07049913
TBE Zone 2 PMS in Japan
GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance in Japan
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2034-02-01
- Completion
- 2034-02-01
- First posted
- 2025-07-03
- Last updated
- 2026-02-05
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07049913. Inclusion in this directory is not an endorsement.