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PRESERVE trial will evaluate safety, effectiveness of inferior vena cava filters

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The large-scale PRESERVE trial is underway to evaluate the safety and effectiveness of inferior vena cava filters. As of mid-December, researchers have activated the first 10 medical sites and enrolled the first nine patients, according to a press release.

PRESERVE is the first multispecialty, prospective, multicenter, open-label, nonrandomized investigation of the real-world safety and effectiveness of commercially available retrievable and permanent inferior vena cava (IVC) filters from seven manufacturers for the prevention of pulmonary embolism, according to the study details on ClinicalTrials.gov. Researchers for the 5-year study are expected to enroll 2,100 patients at 60 U.S. sites (300 patients per device), according to the release.

The study is overseen by the IVC Filter Study Group Foundation, which is sponsored by the Society for Vascular Surgery (SVS) and the Society of Interventional Radiology (SIR). David Gillespie, MD, chief of vascular and endovascular surgery at Southcoast Health System in Fall River, Massachusetts, and Matthew S. Johnson, MD, FSIR, professor of radiology and surgery at Indiana University School of Medicine, are co-principal investigators of the PRESERVE trial.

“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,” Johnson stated in the release. “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 implementation.”

It is estimated that approximately 250,000 patients receive IVC filters each year, according to the release. IVC filter use has changed in recent years. Trauma patients are more likely to receive treatment in an emergency setting, which create challenges with follow-up and removal of the IVC filters. PRESERVE will enroll patients who agree to follow-up for 3 years, according to the release.

“The treatment of deep vein thrombosis in trauma patients has challenged physicians to know the best way to take care of those patients,” Gillespie stated in the release. “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.”