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Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

NCT02777528 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-06-25

Study results available
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Summary

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Conditions

  • Aortic Aneurysm, Thoracic
  • Aorta, Lesion

Interventions

DEVICE

GORE® TAG® Thoracic Branch Endoprosthesis

Endovascular repair with the TBE Device

PROCEDURE

Revascularization Procedure

Revascularization procedure of the great vessel

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Michael Dake, MD · Stanford University

  • Himanshu Patel, MD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2024-03-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777528 on ClinicalTrials.gov