About the PRESERVE Trial
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) directly addresses 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 was 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 provided financial support to the IVC Filter Study Group Foundation to support the PRESERVE study.
Participating IVC Filter Manufacturers
Members of the IVC Filter Study Group Foundation also worked with the contract research organization New England Research Institutes (NERI).
PRESERVE enrollment officially closed on March 31, 2019, with a total of 1,430 subjects by 54 sites. All subjects will continue to be followed for up to 2 years after enrollment. A total of 7 filter manufacturers participated in the trial.
- Matthew S. Johnson, MD, FSIR, Indiana University School of Medicine, Indianapolis, Ind.
- David L. Gillespie MD, FACS, Southcoast Health System, Fall River, Mass.