Long-term Study of GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System in Treating Descending Thoracic Aorta Conditions

What this Trial Is About

This research focuses on collecting long-term data on patients treated with the GORE4 TAG4 Conformable Thoracic Stent Graft with ACTIVE CONTROL System as part of routine clinical care. It aims to evaluate the outcomes of thoracic endovascular aortic repair TEVAR for lesions in the descending thoracic aorta over a period of ten years. The study is observational and prospective, intended to provide information on how well this treatment option works for carefully selected patients. Participants in this study have received or are planned to receive the GORE4 TAG4 Conformable Thoracic Stent Graft with ACTIVE CONTROL System device during their TEVAR procedure. Since this is an observational registry, the device is used as part of usual medical practice rather than as a study-assigned treatment. The study tracks outcomes related to the procedure and device over a long-term follow-up of up to ten years, capturing various clinical events and device performance measures. Throughout the study, participants will be monitored for technical success of device deployment, mortality related to the treated lesion, and complications such as lesion rupture, enlargement, endoleaks, device migration, stroke, paraplegia, renal issues, and need for reintervention. The study collects data on these outcomes during the index procedure and through the ten-year follow-up period. Follow-up visits and data collection occur according to standard care guidelines, and participant safety and device integrity are carefully observed over time.

Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance