Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter

Completed · Phase 4

Conditions studied: Pulmonary Embolism, Venous Thromboembolism

In brief

The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.

Key facts

Study ID

NCT00196118

Run by

Cook Group Incorporated

People needed

800

Starts

2005-04-01

Expected to finish

2007-07-01

Last updated by the study team

2007-12-11

Who can join

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

You may qualify if…

• Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.
• Patient must have a patent internal jugular vein.
• Patient has given informed consent.

You may not qualify if…

• Patient is less than 18 years.
• Patient has a pre-existing filter
• Patient had indications for a permanent filter at the time of the initial evaluation.
• Patient has uncontrollable coagulopathy.
• Patient has a short life expectancy < 6 months.
• Patient has metastatic malignancy.
• Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
• Patient has a contrast allergy that cannot be adequately pre-medicated.
• Patient is at risk of septic embolism.
• Patient has sepsis.
• Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.
• Patient has impaired renal function (creatinine > 2.0).
• Patient is pregnant or planning to become pregnant within the next 6 months

Where it is running

• Christiana Hospital — Newark, Delaware, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Atlanta Medical Center — Atlanta, Georgia, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Spectrum Health Butterworth & Blodgett Campuses — Grand Rapids, Michigan, United States
• Oregon Health & Sciences University — Portland, Oregon, 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
• Utah Valley Regional Medical Center Department of Radiology — Provo, Utah, United States
• LDS Hospital: Department of Radiology — Salt Lake City, Utah, United States
• INOVA Alexandria — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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