National Inferior Vena Cava (IVC) Filter Registry

June 20, 2013 updated by: American Venous Forum

IVC Filter Study to Monitor and Measure Patients Outcomes Through Standardized Collection and Analysis of Clinical Information

Inferior vena cava (IVC) filter is an important therapeutic device used in the management of venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation therapy. While there has been significant increase in the use of filters , unfortunately there are no standardized collection of data to track, compare outcomes, report safety and efficacy.

Study Overview

Status

Terminated

Conditions

Detailed Description

The registry is a multi-institutional bioinformatics database for the collection of data relevant to Inferior vena cava filters. Participating study centers may enroll patients and enter data in the web-based registry that include demographics, clinical features, management details and follow-up up to 48 months.

The purpose of this study is to improve our understanding of the retrieval rate, long term safety and efficacy on IVC filters placed in North America.

Study Type

Observational

Enrollment (Actual)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80211
        • Exempla Lutheran Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida , Division of Vascular Surgery & Endovascular Therapy
      • St Petersburg, Florida, United States, 33701
        • Bayfront Medical Center
    • Georgia
      • Macon, Georgia, United States, 31201
        • Medical Center of Central Georgia
    • Idaho
      • Idaho Falls, Idaho, United States, 83401
        • Eastern Idaho Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals
      • Springfield, Illinois, United States, 62794
        • Southern Illinois University School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University Of Kentucky , Vascular and Endovascular Divison
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Tuoro Infirmary
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5867
        • University of Michigan Health System
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Luke's Medical Center
    • Montana
      • Helena, Montana, United States, 59601
        • St Peters Hospital
    • New York
      • New York, New York, United States, 11201
        • Brooklyn Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center, Vein Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Toledo, Ohio, United States, 43601
        • Jobst Vascular Institute
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh School of Medicine Division of Vascular Surgery
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Palmetto Health and Providence Hospital
      • Greenville, South Carolina, United States, 29605
        • Vascular Health Alliance, Greenville Hospital System
    • South Dakota
      • Yankton, South Dakota, United States, 57078
        • Avera Sacred Heart Hospital
    • Texas
      • Amarillo, Texas, United States, 79106
        • Northwest Texas Hospital
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

No specific criteria. Data from anyone who underwent IVC Filter Placement/Retrieval will be eligible

Description

Inclusion Criteria:

  • Data obtained in line with good clinical practice,applicable laws and regulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Integrity of IVC Filter 12 months post placement
Time Frame: 48 Months
48 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Venous Forum

Investigators

  • Study Chair: Brajesh K Lal, University of Maryland Medical Center,Baltimore
  • Principal Investigator: John E. Rectenwald, University of Michigan
  • Study Director: Uchenna N Onyeachom, American Venous Forum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

June 3, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVR-IVC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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