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

This study has been completed.
Study NCT00196118.   Last updated on December 7, 2007.   Information provided by Cook

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Descriptive Information Fields
Brief Title  Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
Official Title  A Non-Randomized Prospective Study of IVC Filter Retrieval
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 thromboembolism.

Detailed Description
Study Phase Phase IV
Study Type  Interventional
Study Design  Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  The rate of successful filter retrieval following implant.
Secondary Outcome Measure  The rate of complications related to Inferior Vena Cava Filter use.
Condition  Pulmonary Embolism
Venous Thromboembolism
Intervention  Device: Günther Tulip Vena Cava Filter
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  800
Start Date  April 2005
Completion Date July 2007
Eligibility Criteria 

Inclusion Criteria:

  • 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 Criteria:

  • 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00196118
Organization ID 04-507-01
Secondary IDs ††
Study Sponsor  Cook
Collaborators ††
Investigators 
Principal Investigator:     Bob Smouse, MD     Peoria Radiology Research & Education Foundation    
Information Provided By Cook
Verification Date December 2007
First Received Date  September 12, 2005
Last Updated Date December 7, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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