GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorW.L.Gore & Associates
About this trial
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.
Eligibility criteria
Qualifiers
Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.
Patient is age ≥ 18 years at time of informed consent signature.
Disqualifiers
Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
Patient with exclusion criteria required by local law.
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.
Trial design
Treatments tested in this trial
- GORE® TAG® Thoracic Branch Endoprosthesis
Treatment groups
125 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov