Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.
• Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
• Age ≥18 years at time of informed consent signature
• Subject is capable of complying with protocol requirements, including follow-up
• Informed Consent Form (ICF) is signed by Subject or legal representative
• Must have appropriate proximal aortic landing zone.
• Must have appropriate target branch vessel landing zone.
• For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
• Native aortic valve (Zone 0/1 subjects only)
• Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)