Research

PRESERVE Leadership and Study Design

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.

For more information visit Clinicaltrials.gov NCT02381509

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PRESERVE Leadership and Study Design

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