Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around
Principal Investigator
by Andrew Barleben, MD

Description

Summary

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.

Details

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.

Keywords

Aortic Arch Dissection, Aortic Arch Aneurysm, Zone 0, Zone 1, Thoracic Aorta Dissection, GORE® TAG® Thoracic Branch Endoprosthesis, GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)

Eligibility

You can join if…

Open to people ages 18 years and up

  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
  3. Patient is age ≥ 18 years at time of informed consent signature.

You CAN'T join if...

  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.

Locations

  • University of California Davis Health System accepting new patients
    Sacramento California 95817 United States
  • Keck Medical Center of USC accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UC Davis

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
W.L.Gore & Associates
ID
NCT07166133
Study Type
Interventional
Participants
Expecting 125 study participants
Last Updated