Study of GORE4 TAG4 Thoracic Branch Endoprosthesis Device for Treating Aortic Arch Dissection and Aneurysm in Zone 01 with Long-Term Follow-Up

What this Trial Is About

This research aims to collect long-term outcomes for patients treated with the GORE4 TAG4 Thoracic Branch Endoprosthesis TBE Device in Zone 0 or Zone 1 of the aortic arch during routine clinical care. The study plans to include at least 125 subjects across up to 50 sites in the United States, following patients for a minimum of 5 years and up to 10 years after the procedure to gather detailed safety and effectiveness data. Participants will have the TBE Device implanted as part of their clinical treatment for aortic arch dissection or aneurysm. Follow-up visits are scheduled at 1 month, 6 months, 1 year, and then annually for up to 10 years. The study will monitor various outcomes including device technical success, procedure-related complications, stroke, paraplegia, renal failure, device integrity, and lesion-related events over both short and long-term periods. During the study, participants will attend scheduled follow-ups for clinical evaluations and imaging to assess device performance and health status. Researchers will collect data on adverse events, device-related complications, and overall survival measures. This long-term monitoring aims to provide comprehensive information about the safety and durability of the TBE Device in patients treated in routine practice, with total participation lasting up to 10 years.

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study