Gore TAMBE PAS - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are dong this study to collect information about the use of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device). The TAMBE Device was approved by the FDA in 2024 for use in endovascular repair as a treatment for patients with thoracoabdominal and pararenal aortic aneurysms. We want to get data about how well the device performs in the patients who choose to get this implant.

¿Cuál es la Condición que se está estudiando?

Thoracic Aortic Disease

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

  • Have aortic disease in need of endovascular repair
  • Plan to get the Gore TAMBE device for treatment

For more information, please contact the study team at hillary.hood@duke.edu.

Grupo etario
Adultos

¿Qué Implica?

If you choose to join this study, we will schedule you for follow-up visits following your procedure to implant the Gore TAMBE device. These visits will include physical exams, blood draws, CT scans, and neurological testing. The visits will happen according to the following schedule:

  • 1 month after your procedure
  • 6 months after your procedure
  • Once per year for 10 years after the second visit

Detalles del Estudio

Título Completo
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Investigador Principal
Especialista en cirugía cardíaca
Número de Protocolo
IRB: PRO00116971
NCT: NCT06578741
Fase
Fase N/A
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción