Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Andrew Barleben, MD (ucdavis)

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 University of California Health

  • Andrew Barleben, MD (ucdavis)
    Professor, Med: Surgery, School of Medicine. Authored (or co-authored) 62 research publications

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