Suspended

SSB 11-02Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

GORE® TAG® Thoracic Branch Endoprosthesis

+ Revascularization Procedure

DeviceProcedure
Who is being recruted

Aneurysm+3

+ Aortic Aneurysm

+ Aortic Diseases

Over 18 Years
+35 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2016
See protocol details

Summary

Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2016

Actual date on which the first participant was enrolled.

For Zone 0/1, there are two arms (Aneurysm arm, Non-aneurysm arm) and three cohorts, described as follows: Zone 0/1 Aneurysm, Zone 0/1 Dissection, and Zone 0/1 Other Isolated Lesion. The Zone 0/1 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 0/1 Subjects enrolled for analysis were from the United States and Japan.

Official TitleEvaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1
NCT02777528
Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

79 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AneurysmAortic AneurysmAortic DiseasesCardiovascular DiseasesVascular DiseasesAortic Aneurysm, Thoracic

Criteria

9 inclusion criteria required to participate
Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
Age ≥18 years at time of informed consent signature
Subject is capable of complying with protocol requirements, including follow-up
Informed Consent Form (ICF) is signed by Subject or legal representative
Show More Criteria
26 exclusion criteria prevent from participating
Patient at high risk of neurological event, e.g. stroke
Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Previous endovascular repair of the ascending aorta
Previous endovascular repair of the DTA with a non-Gore device
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Zone 0/1 Aortic aneurysm

Group II

Includes dissection and other isolated lesion types

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 39 locations

Suspended

University of Pittsburgh Medical Center

Pittsburgh, United StatesOpen University of Pittsburgh Medical Center in Google Maps
Suspended

Cardiovascular Surgery Clinic

Memphis, United States
Suspended

Vanderbilt University Medical Center

Nashville, United States
Suspended

Morinomiya Hospital

Osaka, Japan
Suspended39 Study Centers