Study Results
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View full resultsBasic Information
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COMPLETED
NA
473 participants
INTERVENTIONAL
2014-01-31
2019-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Temporary or permanent filter placement for the prevention of pulmonary embolism
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters
Temporary or permanent filter placement for the prevention of pulmonary embolism
Interventions
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Günther Tulip® Vena Cava Filter
Temporary or permanent filter placement for the prevention of pulmonary embolism
Cook Celect® Vena Cava Filters
Temporary or permanent filter placement for the prevention of pulmonary embolism
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
* Known allergy or sensitivity to cobalt, chromium, or nickel
* Pregnant or planning to become pregnant in the next 12 months
* Patient refuses blood transfusions
* At risk of septic embolism
* Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
* Existing IVC filter
* Duplicate IVC
* Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
* IVC diameter \> 30 mm or \< 15 mm
18 Years
ALL
No
Sponsors
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Cook Research Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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H. Bob Smouse, MD
Role: PRINCIPAL_INVESTIGATOR
OSF St. Francis/Peoria Radiology Research and Education Foundation
Robert Feezor, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida Health-Shands
Locations
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Abrazo Arrowhead Campus
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Florida Health - Shands
Gainesville, Florida, United States
Miami Cardiac and Vascular Institute
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Coastal Vascular and Interventional
Pensacola, Florida, United States
University of Chicago
Chicago, Illinois, United States
OSF St. Francis/Peoria Radiology Research and Education Foundation
Peoria, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Stony Brook Medicine
Stony Brook, New York, United States
North Carolina Memorial Hospital
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Methodist Hospital - Smith Tower
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Southampton General Hospital
Southampton, Hampshire, United Kingdom
The Royal Liverpool University Hospital
Liverpool, Meyerside, United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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12-018
Identifier Type: -
Identifier Source: org_study_id
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