GREAT Registry for Gore's Endovascular Aortic Devices Achieves Enrollment Milestone

February 25, 2015—Gore & Associates has reported that more than 2,500 patients have been enrolled in the Gore GREAT (Global Registry for Endovascular Aortic Treatment) outcomes evaluation registry, which is part of the company’s postmarket surveillance and monitoring of long-term device performance to improve clinical practice and patient outcomes. The latest registry findings and outcomes will be presented in April at the 2015 Charing Cross International Symposium in London, United Kingdom, and in June at the Vascular Annual Meeting in Chicago, Illinois.

According to the company, the GREAT registry is currently composed of 2,511 patients at 84 sites in 13 countries to demonstrate the performance of the Gore product portfolio. The registry tracks outcomes during patient treatment and posttreatment visits for up to 10 years. In addition to procedural and clinical outcomes, data collected include the device used, treatment indication, patient demographics, and medical history.

Since August 2010, GREAT has collected data on patients treated with the Gore TAG thoracic endoprosthesis, the Conformable Gore TAG thoracic endoprosthesis, the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis, the Gore Excluder AAA endoprosthesis with the C3 delivery system, and the Gore Excluder iliac branch endoprosthesis. The registry will enroll a total of 5,000 consecutive patients from up to 300 worldwide sites with treatment results to be tracked for 10 years.

Gore advised that, to date, 80% of the GREAT procedures have been endovascular aneurysm repair, 16% were thoracic endovascular aneurysm repair, and 4% were other endovascular procedures. The most commonly treated pathologies have been AAA (72%), iliac aneurysms (10%), descending thoracic aortic aneurysms (7%), and type B dissections (3%).

In Gore’s press release, Ross Milner, MD, a GREAT Principal Investigator, commented, “What separates the Gore registry from other medical registries is the minimal exclusion criteria, unprecedented number of patients, and length of follow-up. The active tracking of long-term device performance and associated patient outcomes will provide key insights into real-world clinical practice, which is vital to advancing the future of endovascular repair and improving patient outcomes.” Dr. Milner is Professor of Surgery, Co-Director, Center for Aortic Diseases, and Associate Program Director, Vascular Surgery Fellowship at the University of Chicago Medical Center in Chicago, Illinois.

Piergiorgio Cao, MD, Chief of Vascular Surgery at San Camillo Forlanini Hospital in Rome, Italy, and a GREAT Principal Investigator, added, “GREAT demonstrates the collaborative dedication of physicians around the world to advance patient care. We want to ensure that patients are receiving optimal treatment through safe therapies.”