Clinical trial NCT01367184: National Inferior Vena Cava (IVC) Filter Registry
Official title: IVC Filter Study to Monitor and Measure Patients Outcomes Through Standardized Collection and Analysis of Clinical Information
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Venous Thrombo-embolism
Keywords: VTE
Inferior vena cava
Venous thrombo-embolism
Outcome data
IVC Filters
Lead sponsor: American Venous Forum
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No specific criteria. Data from anyone who underwent IVC Filter Placement/Retrieval will be eligible

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.

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Integrity of IVC Filter 12 months post placement
timeFrame: 48 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Exempla Lutheran Medical Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida , Division of Vascular Surgery & Endovascular Therapy
state: Florida
city: St Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: Eastern Idaho Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Lexington
country: United States
facility: University Of Kentucky , Vascular and Endovascular Divison
state: Kentucky
city: New Orleans
country: United States
facility: Tuoro Infirmary
state: Louisiana
city: Ann Arbor
country: United States
facility: University Of Michigan Health System
state: Michigan
city: Chesterfield
country: United States
facility: St. Luke's Medical Center
state: Missouri
city: Helena
country: United States
facility: St Peters Hospital
state: Montana
city: New York
country: United States
facility: Brooklyn Hospital
state: New York
city: Rochester
country: United States
facility: University Of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center, Vein Clinic
state: New York
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine Division of Vascular Surgery
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health and Providence Hospital
state: South Carolina
city: Greenville
country: United States
facility: Vascular Health Alliance, Greenville Hospital System
state: South Carolina
city: Yankton
country: United States
facility: Avera Sacred Heart Hospital
state: South Dakota
city: Amarillo
country: United States
facility: Northwest Texas Hospital
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Morgantown
country: United States
facility: West Virginia University Healthcare
state: West Virginia
Study officials:
affiliation: University of Maryland Medical Center,Baltimore
name: Brajesh K Lal
role: STUDY_CHAIR
affiliation: University of Michigan
name: John E. Rectenwald
role: PRINCIPAL_INVESTIGATOR
affiliation: American Venous Forum
name: Uchenna N Onyeachom
role: STUDY_DIRECTOR
References: