Overview: VISION is an observational study that observes post-market reporting and post-market surveillance in patients over the age of 65 who utilize vascular devices such as those used for endovascular abdominal aortic aneurysm repair. VISION matches procedures in the Society for Vascular Surgery Patient Safety Organization (SVS-PSO) registry – more than 400,000 to date – with Medicare claims and New York State Registry data (SPARCS). VISION has two aims from these results: a) to expand VISION by introducing under-65 all-payer populations, and b) validating against trials for a novel, inexpensive path to real-world evidence.
Impact for NESTcc: The use of Real-World Data (RWD) through Registry and Medicare Claims Data will increase efficiency, validity, and cost of device surveillance.
Organization(s): Society for Vascular Surgery Patient Safety Organization, U.S. Food and Drug Administration (FDA), Weill Cornell Medical Center
Principal Investigator(s): Philip Goodney, MD, MS and Art Sedrakyan, MD, PhD for the Society for Vascular Surgery Patient Safety Organization (SVS-PSO)