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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00196118
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 11, 2007
Sponsor:
Information provided by:
Cook Group Incorporated

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date December 11, 2007
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
The rate of successful filter retrieval following implant.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
The rate of complications related to Inferior Vena Cava Filter use.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Pulmonary Embolism
  • Venous Thromboembolism
Intervention  ICMJE Device: Günther Tulip Vena Cava Filter
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
800
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00196118
Other Study ID Numbers  ICMJE 04-507-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cook Group Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bob Smouse, MD Peoria Radiology Research & Education Foundation
PRS Account Cook Group Incorporated
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP