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National Inferior Vena Cava (IVC) Filter Registry

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ClinicalTrials.gov Identifier: NCT01367184
Recruitment Status : Terminated
First Posted : June 7, 2011
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
American Venous Forum

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.

Condition or disease
Venous Thrombo-embolism

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
Actual Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IVC Filter Study to Monitor and Measure Patients Outcomes Through Standardized Collection and Analysis of Clinical Information
Study Start Date : May 2011
Primary Completion Date : April 2013
Estimated Study Completion Date : May 2014



Primary Outcome Measures :
  1. Integrity of IVC Filter 12 months post placement [ Time Frame: 48 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
No specific criteria. Data from anyone who underwent IVC Filter Placement/Retrieval will be eligible
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367184


  Show 27 Study Locations
Sponsors and Collaborators
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

Additional Information:
Responsible Party: American Venous Forum
ClinicalTrials.gov Identifier: NCT01367184     History of Changes
Other Study ID Numbers: AVR-IVC-01
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by American Venous Forum:
VTE
Inferior vena cava
Venous thrombo-embolism
Outcome data
IVC Filters

Additional relevant MeSH terms:
Embolism
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases