Over the next few months, sites will be selected for the first large-scale, multi-specialty, prospective clinical research trial to evaluate IVC filters in the United States.
A collaboration between SVS and the Society of Interventional Radiology, the five-year trial will evaluate an August 2010 FDA medical alert that retrievable IVC filters could move or break, causing possible health risks. The trial has been named PRESERVE, for Predicting the Safety and Effectiveness of Inferior Vena Cava Filters. The two associations formed the IVC Filter Group Study Foundation to oversee the study.
“The PRESERVE study will benefit patients by helping determine how well filters prevent pulmonary embolism and when retrievable filters should be removed,” noted Peter Lawrence, M.D., foundation vice president.
Co-principal investigators are David L. Gillespie M.D., FACS, Chief of the Department of Vascular and Endovascular Surgery at Southcoast Health in Fall River, Mass., and Matthew S. Johnson, M.D., FSIR, Indiana University School of Medicine, Indianapolis, Ind.
Dr. Gillespie’s involvement is the natural outgrowth of his long-term experience and interest in vena cava filters. The issue became more acute, he said, as wounded soldiers came home from Iraq and Afghanistan, in need of therapeutic or prophylactic vena cava filters to prevent complications from venous thromboembolism.
“Questions arose about the efficacy and safety of prophylactic use of IVC filters prompting me to get more involved locally and nationally,” he said. The study is an attempt to “push this in the right direction to help the industry partners, the FDA, the SVS and our patients come to a consensus on what is safe and effective in regard to these devices.”
Filter manufacturers are providing financial support to the IVC Filter Study Group Foundation to sponsor 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); Cordis Corporation (Cordis OptEase® Retrievable Vena Cava Filter/ Cordis TrapEase® Vena Cava Filter); and Volcano Corporation (Crux® Vena Cava Filter System).The study will enroll 2,100 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.