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Gore TBE 25-03 PAS

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Description

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.

Details

Full study title GORE? TAG? Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Protocol number OCR50033
ClinicalTrials.gov ID NCT07166133
Phase N/A

Eligibility

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.

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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    Participate

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