According to the U.S. Surgeon General, between 350,000 and 600,000 people each year in the United States are affected by blood clots, and between 100,000 and 180,000 people die of pulmonary embolism (a blood clot that travels to the lungs) each year. Inferior Vena Cava (IVC) filters are placed inside patients by vascular specialists to prevent blood clots from traveling to the lungs and causing a pulmonary embolism. The Food and Drug Administration (FDA) recommendations are that physicians remove the filters, which are designed to be retrievable, once the threat of pulmonary embolism has passed. The FDA warning stated that all physicians were encouraged to consider the benefits and health risks of IVC filter removal for each patient.
Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) will directly address an August 2010 FDA medical alert detailing the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients. PRESERVE is the first large-scale, multi-specialty prospective clinical research trial to evaluate IVC filters use and long term follow-up. The goal of the PRESERVE study is to obtain a real world view of the safety and effectiveness of participating commercially available filters placed in the United States.
The Society of Interventional Radiology (SIR) and the Society of Vascular Surgery (SVS) have collaboratively formed the IVC Filter Study Group Foundation, a 501(c)(3) not-for-profit entity that sponsors and oversees PRESERVE. Filter manufacturers are providing financial support to the IVC Filter Study Group Foundation to support the PRESERVE study. The manufacturers and devices that will be included in the study are ALN Implants Chirurgicaux (ALN Vena Cava Filters); Argon Medical Devices, Inc. (Option™ Elite Retrievable Vena Cava Filter designed and manufactured by Rex Medical); B. Braun Interventional Systems Inc. (VenaTech® LP Vena Cava Filter); Bard Peripheral Vascular, Inc. (DENALI® Vena Cava Filter System); Cook Incorporated (Cook Günther Tulip Vena Cava Filter); and Cordis Corporation (Cordis OptEase® Retrievable Vena Cava Filter/ Cordis TrapEase® Vena Cava Filter). Members of the IVC Filter Study Group Foundation also have been working with the contract research organization New England Research Institutes (NERI).
The five-year study will evaluate the overall safety and efficacy of IVC filters placed by doctors, and it intends to enroll 1,800 patients at approximately 60 centers in the United States. There will be at least 300 patients enrolled for each participating manufacturer filter, and patients will be evaluated every six months post procedure up to 24 months or filter retrieval. Principal Investigators are Matthew S. Johnson, MD, FSIR, Indiana University School of Medicine, Indianapolis, Ind., and David L. Gillespie MD, FACS, Southcoast Health System, Fall River, Mass.