GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
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Clinical Trial Information
Trial Contact: Ngo, George M.; Cox, Caitlin L; Harms, Gabrielle T
Trial Phone: 3218439657 ; 321-841-1505 ; 4077012135
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IRB No: W24.141.09
Protocol Abbrev: TAMBE AAA 24-01
Principal Investigator: Aleem Mirza, MD
Phase: Device: Non-significant Risk
Age Group: Adult
Treatment: The Study Device is the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device), which will be placed inside the aorta to block the injured part of the artery wall from the blood pressure that could lead to rupture and still allow blood flow to the rest of your body. Because the aortic disease involves the visceral branch vessels that carry blood to organs in your abdomen, components of the Study Device will be placed in these vessels to keep blood flowing to the organs.
ClinicalTrials.gov ID: NCT06578741
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Objective
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
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Key Eligibility
Patients who receive the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) Aortic Component used in endovascular repair
