• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Medical societies to launch large-scale study on vein filter use

Medical societies to launch large-scale study on vein filter use

February 4, 2013
CenterWatch Staff

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.

Upcoming Events

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing