The Society of Interventional Radiology (SIR) and the Society for Vascular Surgery (SVS) are planning to plan to launch a large-scale, multispecialty prospective study to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment.
The societies have also established the IVC Filter Study Group Foundation.
The trial, called the Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) study, has a goal of obtaining a functional view of all filters placed in the U.S. The five-year study will evaluate the overall safety and efficacy of filters placed by physicians. About 50 medical centers are expected to participate, enrolling 1,800 patients.
Most filter manufacturers have agreed to participate in the study, according to SIR and SVS. Its co-directors are Dr. Matthew S. Johnson, a professor of radiology and surgery at the Indiana University School of Medicine, and Dr. David L. Gillespie, a professor in the division of vascular surgery of the University of Rochester Medical Center School of Medicine and Dentistry.
Both the study and the formation of the foundation are direct actions taken by the societies to address a medical alert issued in August 2010 by the U.S. Food and Drug Administration. This alert detailed the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients.
