Status:
COMPLETED
Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
Lead Sponsor:
Cook Group Incorporated
Conditions:
Pulmonary Embolism
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00196118
Start Date
April 1 2005
End Date
July 1 2007
Last Update
December 11 2007
Active Locations (17)
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1
Christiana Hospital
Newark, Delaware, United States, 19718
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute
Miami, Florida, United States, 33176
4
Atlanta Medical Center
Atlanta, Georgia, United States, 30312