NCT01367184

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

27 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

June 3, 2011

Last Update Submit

June 20, 2013

Conditions

Keywords

VTEInferior vena cavaVenous thrombo-embolismOutcome dataIVC Filters

Outcome Measures

Primary Outcomes (1)

  • Integrity of IVC Filter 12 months post placement

    48 Months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Exempla Lutheran Medical Center

Denver, Colorado, 80211, United States

Location

University of Florida , Division of Vascular Surgery & Endovascular Therapy

Gainesville, Florida, 32610, United States

Location

Bayfront Medical Center

St. Petersburg, Florida, 33701, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho, 83401, United States

Location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

University Of Kentucky , Vascular and Endovascular Divison

Lexington, Kentucky, 40506, United States

Location

Tuoro Infirmary

New Orleans, Louisiana, 70115, United States

Location

University Of Michigan Health System

Ann Arbor, Michigan, 48109-5867, United States

Location

St. Luke's Medical Center

Chesterfield, Missouri, 63017, United States

Location

St Peters Hospital

Helena, Montana, 59601, United States

Location

Brooklyn Hospital

New York, New York, 11201, United States

Location

University Of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center, Vein Clinic

Stony Brook, New York, 11794, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43601, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17601, United States

Location

University of Pittsburgh School of Medicine Division of Vascular Surgery

Pittsburgh, Pennsylvania, 15213, United States

Location

Palmetto Health and Providence Hospital

Columbia, South Carolina, 29201, United States

Location

Vascular Health Alliance, Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Avera Sacred Heart Hospital

Yankton, South Dakota, 57078, United States

Location

Northwest Texas Hospital

Amarillo, Texas, 79106, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26505, United States

Location

Related Links

Study Officials

  • Brajesh K Lal

    University of Maryland Medical Center,Baltimore

    STUDY CHAIR
  • John E. Rectenwald

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Uchenna N Onyeachom

    American Venous Forum

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 7, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2013

Study Completion

May 1, 2014

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations