IVC Filter Study Group Foundation Commences Large-Scale PRESERVE Trial

December 16, 2015—The Society for Vascular Surgery (SVS) and the Society for Interventional Radiology (SIR) announced the commencement of enrollment in the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study. PRESERVE is a large-scale, multispecialty, prospective clinical research trial that will evaluate the real world safety and effectiveness of retrievable inferior vena cava (IVC) filters. In a November 2014 announcement, covered in Endovascular Today, the societies outlined the final plans for the PRESERVE trial.

The organizers have now activated the first 10 medical sites and enrolled the first nine patients in the study. The 5-year study is expected to enroll 2,100 patients at 60 sites in the United States and is overseen by the IVC Filter Study Group Foundation, which is sponsored jointly by SVS and SIR.

The societies noted that the use of IVC filters has undergone revolutionary changes through the years and trauma patients are likely to be treated in an emergency setting and may not follow-up with their physician to get the implants removed. The PRESERVE study is enlisting patients who agree to have their medical care followed for 3 years. 

PRESERVE will study filters produced by seven manufacturers at once, with 300 patients treated per device. The protocol instructs participating physicians to manage the patient exactly as they would if there were no study going on, so that “real world” outcomes can be assessed.

SVS and SIR stated that the trial is a joint venture of the two medical associations working together in an unusual, paradigm-shifting initiative that brings together the US Food and Drug Administration, the medical profession, and multiple device manufacturers. More information about the trial is available at www.PRESERVEtrial.com.

The PRESERVE trial is being led by Coprincipal Investigators David Gillespie, MD, and Matthew S. Johnson. Dr. Gillespie is chief of vascular and endovascular surgery at Southcoast Health System in Fall River, Massachusetts. Dr. Johnson is professor of radiology and surgery at Indiana University School of Medicine in Indianapolis, Indiana.

In the societies’ press release, Dr. Gillespie commented, “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.”

Dr. Johnson added, “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.”

Dr. Johnson recently discussed the PRESERVE trial and IVC filter retrieval protocol in an “Ask the Experts” article on IVC filter use with four other leading interventionists in Endovascular Today (2015;14:53–58). In November 2012, he provided an early preview, along with a survey of the background and development, of the PRESERVE trial in an interview published in Endovascular Today (2012;11:65–68).