GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

The subject is / has:

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/15/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Randall DeMartino, M.D., M.S.

Contact us for the latest status

Contact information:

Jessica Schneider CCRP

(507) 255-7249

Schneider.Jessica1@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Victor Davila-Garcia, M.D.

Contact us for the latest status

Contact information:

Thierry Ilela

(480) 342-2906

ilela.thierry@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20588049

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