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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2036-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Arch Dissection Aortic Arch Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

GORE® TAG® Thoracic Branch Endoprosthesis (TBE)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)

Group Type OTHER

GORE® TAG® Thoracic Branch Endoprosthesis

Intervention Type DEVICE

Lesions in aortic arch in Zone 0 or Zone 1

Interventions

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GORE® TAG® Thoracic Branch Endoprosthesis

Lesions in aortic arch in Zone 0 or Zone 1

Intervention Type DEVICE

Eligibility Criteria

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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.
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No