The Terumo Aortic Global Endovascular Registry: A Multiarm, Multicenter, Open Label, Prospective Observational Registry to Obtain Safety and Performance Data on off-the-Shelf and Custom-Made Stent-Grafts.

Abstract

Background: Approval of medical devices is typically based on data from relatively small clinical studies with a highly selected patient population. Postmarket surveillance is required by regulatory bodies after approval to collect and evaluate experience gained from real world use in larger and unselected populations. Terumo Aortic is a manufacturer of off-the-shelf and custom-made stent-grafts for endovascular repair of thoracic and abdominal aortic pathologies and is assessing device performance in a large registry.

Methods: A multiarm, multicenter, open label, prospective observational registry designed to obtain both short- and long-term safety and performance data on the use of standard and custom-made Terumo Aortic endovascular devices in patients with thoracic and abdominal aortic pathologies. Eligibility requirements are minimal, and a standard-of-care protocol will ensure real-world evidence is collected as far as 10 years.

Discussion: Challenges to this research reflect its real-world nature such as differences in standard of care between centers and geographies, varying levels of experience and expertise with the devices or techniques, all-comer populations that may not always be comparable, and a design specifically limited to a single manufacturer. Advantages of this registry design include long-term follow-up, different modules to collect standardized outcomes across pathologies and global reach to reflect practice in many different geographies with a wide range of latest-generation endovascular devices.

Conclusion: This protocol is a large endovascular registry of all aortic pathologies that are treated by both off-the-shelf and custom-made Terumo Aortic products. It is ambitious in scope and projection and will be part of an overall response involving patients, physicians, and manufacturers to answer the remaining questions of endovascular aortic repair, contribute to continuing improvement of the techniques and technologies, and present an accurate picture of outcomes with latest generation stent-graft devices.Clinical ImpactThis large, long-term registry will generate robust real-world evidence on the safety and performance of both standard and custom-made Terumo Aortic endovascular devices in treating thoracic and abdominal aortic pathologies. By including a broad, minimally selected patient population across diverse global centers, the study mirrors everyday clinical practice and helps bridge the gap between clinical trials and real-world outcomes. Its findings will inform clinical decision-making, support regulatory compliance, and guide ongoing device development. Ultimately, the registry aims to enhance patient care by improving the understanding of endovascular treatment effectiveness and long-term durability in heterogeneous populations.