Cook IVC Filter Study

Completed · Not applicable

Conditions studied: Pulmonary Embolism

In brief

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).

Key facts

Study ID

NCT02046096

Run by

Cook Research Incorporated

People needed

473

Starts

2014-01-01

Expected to finish

2019-08-09

Last updated by the study team

2022-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Requires temporary or permanent IVC filter placement for the prevention of PE

You may not qualify if…

• Less than 18 years of age
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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