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

Purpose

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.

Conditions

  • Aortic Arch Dissection
  • Aortic Arch Aneurysm

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
GORE® TAG® Thoracic Branch Endoprosthesis (TBE)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)
  • Device: GORE® TAG® Thoracic Branch Endoprosthesis
    Lesions in aortic arch in Zone 0 or Zone 1

Recruiting Locations

Lakeland Regional Medical Center
Lakeland, Florida 33805
Contact:
Mohammed Hassan, MD
863-413-5969
mohammed.hassan@mylrh.org

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Matthew Sweet, MD
206-598-8487
mpsweet@uw.edu

More Details

Status
Recruiting
Sponsor
W.L.Gore & Associates

Study Contact

DeAnne Hart
800-437-8181
tbe25-03@wlgore.com

Detailed 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.