The Society of Interventional Radiology (SIR) and Society for Vascular Surgery (SVS) jointly will launch PRESERVE—the first large-scale, multi-specialty prospective study to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment.
The study, along with the formation of the IVC Filter Study Group Foundation, are direct actions taken to address the August 2010 FDA medical alert detailing the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients.
SIR and SVS are in the process of determining a framework for the PRESERVE (PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study, with the goal of obtaining a functional view of all filters placed in the U.S.
"PRESERVE data will allow a systematic, functional view, representative of all filters placed in the U.S., thus, all stakeholders—individuals, health care professionals, insurers and government regulators—will be armed with the knowledge they need on patient risk and, subsequently, quality improvement in filter placement, management and retrieval," said Marshall E. Hicks, M.D., FSIR, president of SIR.
Peter Gloviczki, M.D., president of SVS, added, “This is a paradigm-shifting initiative: interventional radiologists and vascular surgeons collaborating to launch a large-scale prospective study evaluating inferior vena cava filters reveals a lot about each specialty's focus--and that focus is on patients, first and foremost.”
The five-year study will evaluate the overall safety and efficacy of filters placed by doctors and intends to enroll 1,800 patients at approximately 50 centers in the U.S. Members of the IVC Filter Study Group Foundation collectively discussed ways to respond to the FDA's stated concerns. SIR and SVS are in the process of making a final decision for a CRO, completing protocol development and submitting the study for investigational device exemption study with HIPAA compliance.
Study directors are Matthew S. Johnson, M.D., FSIR, Indiana University School of Medicine, and David L. Gillespie M.D., FACS, University of Rochester School of Medicine and Dentistry. Most filter manufacturers have agreed to participate in the study.