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TAMBE PAS

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • 网红黑料y Volunteers
    No
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Objective

This study aims to confirm that the benefit-risk assessment of the GORE庐 EXCLUDER庐 Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.

Description

A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.

Details

Full study title GORE EXCLUDER Thoracoabdominal Endoprosthesis Post-approval Study
Protocol number OCR46084
ClinicalTrials.gov ID NCT06578741
Phase N/A

Eligibility

Inclusion Criteria:

The subject is / has:

  1. Treated with the aortic component of the GORE庐 EXCLUDER庐 Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.

  2. Age 鈮�18 years at the time of informed consent signature.

  3. An Informed Consent Form signed by subject or legal representative.

Exclusion Criteria:

The subject is / has:

  1. Any contraindications for the TAMBE Device according to the IFU.

  2. Planned parallel grafting with the TAMBE Aortic Component.

  3. Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).

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

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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