A multi-center, 2,100 patient, 5-year study of inferior vena cava filters has begun enrollment, bringing in its 1st 9 patients at 10 initial medical sites.
The study aims to examine the safety and effectiveness of the small, cage-like devices that are implanted to prevent life-threatening blood clots from reaching the heart or lungs.
“The treatment of deep vein thrombosis in trauma patients has challenged physicians to know the best way to take care of those patients. There are a lot of devices from different manufacturers to choose from. Physicians have been using the retrievable filters with the idea they will retrieve them, but for many reasons they often don’t,” co-principal investigator Dr. David Gillespie of Fall River, Mass.’s Southcoast Health System said in a press release.
The study is being overseen by the IVC Filter Study Group Foundation, which is sponsored by the Society for Vascular Surgery and the Society for Interventional Radiology, according to a press release.
“SIR and SVS have been engaged in ongoing dialogue with the FDA for several years to gather additional data and better understand IVC filter safety and effectiveness. Our foremost commitment is to patient safety, and this study will help determine how well filters prevent pulmonary embolism and how they function over the course of their implantation,” co-principal investigator Dr. Matthew Johnson of the Indiana University School of Medicine said in prepared remarks.
The Preserve trial is the 1st large-scale, multispecialty, prospective clinical research trial to evaluate inferior vena cava filters safety and effectiveness.
The trial will follow 300 patients per device on 7 different devices, with physicians advised to operate as they would in day-to-day treatments to accurately assess “real world” outcomes.