GORE TBE Device in Zone 0/1 for Aortic Arch Conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multi-center post-market study follows patients treated with the TBE device in Zone 0/1 to track outcomes for a minimum of 5 years and up to 10 years. Enrollment targets include at least 125 subjects across up to 50 U.S. sites, with scheduled follow-ups at 1 month, 6 months, 1 year, and annually thereafter. The study observes real-world use after approval, focusing on safety and effectiveness in routine clinical practice. Eligible participants include adults treated with the device in Zone 0/1, with follow-up possible for the specified duration, while maintaining standard post-market monitoring requirements.

Why it matters

Who can join: the full rules

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.

Where it's running

• HonorHealth
  Scottsdale, Arizona, United States Recruiting
• Keck Medical Center of USC
  Los Angeles, California, United States Recruiting
• Stanford University Hospital and Clinics
  Palo Alto, California, United States Recruiting
• University of California Davis Health System
  Sacramento, California, United States Recruiting
• Santa Barbara Cottage Research Institute
  Santa Barbara, California, United States Recruiting
• Hartford Hospital
  Hartford, Connecticut, United States Recruiting

Study contacts

• Study coordinator: DeAnne Hart
• Email: tbe25-03@wlgore.com
• Phone: 800-437-8181

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.