Gore closes enrollment in registry study for Excluder, Tag devices
W.L. Gore & Assoc. said it enrolled the last of more than 5,000 patients in a 10-year, real-world study of its Excluder AAA, Excluder iliac branch and Tag thoracic stent grafts, calling the Great trial “the largest industry-sponsored global registry of aortic stent grafts.”
“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,” co-national investigator Dr. Fred Weaver said in prepared remarks. “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.”
Gore said it created a dedicated team to analyze data from the study and to respond to requests for data from physicians.
“We have already seen that our stent grafts result in long-term durable clinical outcomes,” aortic head Ryan Takeuchi said in prepared remarks. “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.”