National Inferior Vena Cava (IVC) Filter Registry

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
American Venous Forum
ClinicalTrials.gov Identifier:
NCT01367184
First received: June 3, 2011
Last updated: June 20, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by American Venous Forum:

Primary Outcome Measures:
  • Integrity of IVC Filter 12 months post placement [ Time Frame: 48 Months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: American Venous Forum
ClinicalTrials.gov Identifier: NCT01367184     History of Changes
Other Study ID Numbers: AVR-IVC-01
Study First Received: June 3, 2011
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

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
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on July 20, 2014