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National Inferior Vena Cava (IVC) Filter Registry

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367184
First Posted: June 7, 2011
Last Update Posted: June 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
American Venous Forum
  Purpose
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
Venous Thrombo-embolism

Study Type: Observational
Study Design: 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

Further study details as provided by American Venous Forum:

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

Enrollment: 20000
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: American Venous Forum
ClinicalTrials.gov Identifier: NCT01367184     History of Changes
Other Study ID Numbers: AVR-IVC-01
First Submitted: June 3, 2011
First Posted: June 7, 2011
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