GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Launched by W.L.GORE & ASSOCIATES · Aug 27, 2024

Keywords

ClinConnect Summary

This is a real-world, post-approval study to see how the GORE ExCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE Device) works in repairing certain abdominal and thoracoabdominal aortic aneurysms that involve the arteries feeding the abdominal organs. It is a single-arm study, meaning all participants receive the TAMBE device. Up to 300 adults at about 60 U.S. centers will be enrolled, including some centers that are new to using the TAMBE device. After implantation, participants will have follow-up visits at about 1 month, 6 months, 12 months, and then yearly for up to 10 years to track safety and how well the device continues to function.

Eligible people are adults 18 and older who need the TAMBE Aortic Component to repair an aortic aneurysm involving the visceral arteries and can give informed consent. Key inclusion criteria include no contraindications to the TAMBE device and no plan to modify the device or use parallel grafting. Participants should expect an endovascular repair with the TAMBE device and will be assessed for technical success of the procedure and clinical success through the first year (for example, no procedure-related death, no ongoing problematic leaks, no aneurysm growth or rupture, no need for open surgery, and no major complications such as stroke or paralysis), with ongoing safety and durability monitored for up to 10 years. The study is led by Gore and conducted at sites including Stanford, and data may be shared with researchers after de-identification.

Gender

ALL

Eligibility criteria

• 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).