GREAT Global Registry Data Presented for Gore's Endovascular Devices

June 18, 2015—Gore & Associates announced that data from the GREAT (Gore Global Registry for Endovascular Aortic Treatment) real-world endovascular outcomes registry were presented at the Society for Vascular Surgery’s 2015 Vascular Annual Meeting held June 17–20 in Chicago, Illinois. 

The company also noted that the GREAT registry has passed the enrollment milestone of 3,000 patients. A total of 5,000 consecutive patients from up to 300 worldwide sites will be enrolled in the registry, and their treatment results will be tracked for 10 years. 

Since 2010, the GREAT registry 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 featuring C3 delivery system, and the Gore Excluder iliac branch endoprosthesis. 

The registry tracks outcomes during patient treatment and posttreatment visits. In addition to procedural and clinical outcomes, data collected include the device used, treatment indication, patient demographics, and medical history.

During a Vascular Live presentation at the Society for Vascular Surgery's meeting, Ross Milner, MD, who is national coprincipal investigator for GREAT in the United States, and Dennis R. Gable, MD, presented data from patients previously enrolled in GREAT. The presentation included data supporting the limb performance of the Gore Excluder AAA endoprosthesis, which has limbs with a sutureless construction and a fully supported stent designed to prevent kinking and occlusion.

According to the company, in a meta-analysis of several endovascular aneurysm repair devices, the Gore Excluder limbs demonstrated the lowest incidence of occlusion at 1 and 3 years. Additionally, 14.3% of GREAT patients had an aortic bifurcation < 16 mm, and there have been no reported occlusions, compressions, fractures, migrations, or kinking.

The presentation also discussed how clinicians are effectively using the Conformable Gore TAG thoracic endoprosthesis to treat all type B dissections. Through treatment of all type B dissections, there were no reported serious device events during the procedures and no migrations, fractures, or compressions.

In the company’s press release, Dr. Gable commented, “The ability to track such a large number of patients over an extended period of time is something that clearly sets GREAT apart from other registries. This sample will provide us with an unparalleled opportunity to measure patient successes and outcomes that help us make continued improvements in endovascular repair of aortic disease.” Dr. Gable is Chief of Vascular Surgery and Co-Director, Center for Thoracic Aortic Disease at Baylor Plano Heart Hospital and Texas Vascular Associates in Plano, Texas.

Dr. Milner stated, “Device construction, materials, and stent design all have significant impact on the overall outcome of aortic procedures. With more than 17 years of documented success, the Gore Excluder device demonstrates this importance with its proven track record of 0% migration and fracture rates along with very low type I, III, and IV endoleak rates.” 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.