Trials / Recruiting
RecruitingNCT06507865
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.
Detailed description
The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions. Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.
Conditions
- Aneurysm
- Dissection, Aortic
- TAA Thoracoabdominal Aortic Aneurysm
- Thoracic Aortic Aneurysm
- Transection Aorta
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE® TAG® Thoracic Branch Endoprosthesis | Patients presenting with thoracic vascular disease that may benefit from the placement of TBE device. The target registry population is patients who are treated with TBE at participating sites. TBE treatment is qualified as receiving the TBE aortic component, at a minimum. |
Timeline
- Start date
- 2025-02-20
- Primary completion
- 2031-04-01
- Completion
- 2031-04-01
- First posted
- 2024-07-18
- Last updated
- 2025-05-09
Locations
20 sites across 9 countries: Austria, Denmark, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06507865. Inclusion in this directory is not an endorsement.