Clinical trial

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE)

PRESERVE is the first large-scale, multi-specialty prospective clinical research trial to evaluate IVC filters use and long term follow-up.

Clinical trial
Additional info

The PRESERVE Trial is the first large-scale, multi-specialty, prospective clinical study to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment in the United States.

The trial is sponsored by the IVC Filter Study Group Foundation, a joint collaboration between the Society of Interventional Radiology and the Society for Vascular Surgery. 

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About

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.

Leadership

Principal Investigators

  • Matthew S. Johnson, MD, FSIR, Indiana University School of Medicine, Indianapolis, Ind.
  • David L. Gillespie MD, FACS, Southcoast Health System, Fall River, Mass.

The IVC Filter Study Group Foundation

SVS and SIR collaboratively formed the IVC Filter Study Group Foundation, a 501(c)(3) not-for-profit entity that sponsors and oversees PRESERVE.

The IVC Filter Study Group Foundation Board of Directors includes rotating clinician representatives from SIR and SVS:

  • Kenneth Slaw, PhD, Foundation Secretary
  • Susan Sedory, MA, CAE, Foundation Treasurer

The PRESERVE Steering Committee

The PRESERVE Steering Committee is made up of clinical representatives from SVS and SIR.

Co-Chairs:

  • David L. Gillespie, MD, FACS, [David_Gillespie_bio_2.pdf] Southcoast Health System, Fall River, MA
  • Matthew S. Johnson, MD, FSIR, [Matthew_Johnson_Bio.pdf] Indiana University School of Medicine, Indianapolis, IN

Members:

  • James B. Spies, MD, MPH, FSIR, Georgetown University Medical Center, Washington, DC
  • Rodney A. White, MD, Harbor UCLA, Los Angeles, CA
  • John E. Rectenwald, MD, MS, University of Wisconsin, Madison, WI

HealthCore-NERI

HealthCore-NERI serves as the contract research organization responsible for executing the trial. Learn more about HealthCore-NERI at www.neriscience.com.

Clinical Sites

For a complete listing of our clinical sites, please visit ClinicalTrials.gov. 

Study design

The study is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of PE. This study will enroll approximately 1,800 IVC filter subjects at up to 60 sites in the US.

All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 1-month post-retrieval. All subjects who are considered a treatment failure at time of procedure will be followed for 1-month post-procedure.

Mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast or non-contrast abdominal CT). In addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.

There will be 300 subjects enrolled for each IVC filter from participating manufacturers. Once the subject enrollment has been reached per IVC filter, enrollment will be closed for further enrollment of subjects using that particular IVC filter.

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