GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

W.L. Gore & Associates

Status: Begins enrollment this month

Conditions: Aortic Arch Aneurysm; Aortic Arch Dissection

Treatments: Device: GORE® TAG® Thoracic Branch Endoprosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT07166133

TBE 25-03

Details and patient eligibility

About

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Full description

Minimum of 125 total subjects with a TBE Device implantation procedure initiated in up to 50 Sites in the United States. Subjects will have follow-up at 1 Month, 6 Month, 1 Year, and annually thereafter for a minimum of 5-years and up to a maximum of 10 years.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
2. Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.
3. Patient is age ≥ 18 years at time of informed consent signature.

Exclusion criteria

1. Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
2. Patient with exclusion criteria required by local law.
3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study within 12 months of study enrollment. Subjects cannot be enrolled in another Gore study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)

Other group

Treatment:

Device: GORE® TAG® Thoracic Branch Endoprosthesis