W. L. Gore & Associates announced at the VEITHsymposium, the completion of target enrollment in the Global Registry for Endovascular Aortic Treatment (GREAT).
More than 5,000 patients have been enrolled into what is now the largest industry-sponsored global registry of aortic stent-grafts.
Gore undertook the effort in 2010 to evaluate how their family of aortic devices perform in real-world cases and to continue their commitment to advancing patient care in the treatment of aortic disease. The global lead investigators representing each region include Doctors Steven Dubenec, Pierre Galvagni, Ross Milner, Santi Trimarchi, Eric Verhoeven, and Fred Weaver.
To ensure the registry is as reflective of real-world use as possible, Gore opened enrollment in the GREAT study to include patients with all pathologies of the aorta. This includes patients who received one or more of the GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis, or Conformable GORE® TAG® Thoracic Endoprosthesis.
The registry tracks outcomes during treatment and post-treatment over a 10-year follow-up period. In addition to procedural and clinical outcomes, data collected includes device(s) used, disease state treated, patient demographics, and medical history to measure outcomes in various scenarios.
This data will also inform the continual evolvement of the Gore family of aortic stent-grafts for the future.
“While clinical trials are very necessary to see if a device is appropriate and effective, often the results are not reflective of device use in daily practice,” said Fred Weaver, MD, co-national investigator.
“Through GREAT, we can take a look at a large number of patients with a broad set of symptoms and treatments to see how a device performs and make a better determination on proper device use in the future. This registry is truly real-world data.”
GREAT is part of Gore’s dedication to post-market surveillance and monitoring long-term device performance in an effort to improve clinical practice and patient outcomes. A team is dedicated to data analysis stemming from GREAT and ongoing follow-up.
Additionally, the team is available to provide specific data upon request in an effort to aid physicians in making more informed treatment decisions for their patients.
“We have already seen that our stent-grafts result in long-term durable clinical outcomes,” said Ryan Takeuchi, Gore Aortic Business Leader. “Our commitment to the treatment of disease states of the entire aorta will be best informed by these diverse cases over the next decade; we are confident that this data will ultimately translate into better outcomes for patients.”
Now in its 43rd year, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists, and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease.