Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Venous Thromboembolism Device: Günther Tulip Vena Cava Filter Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Non-Randomized Prospective Study of IVC Filter Retrieval
Study Start Date : April 2005
Study Completion Date : July 2007



Primary Outcome Measures :
  1. The rate of successful filter retrieval following implant.

Secondary Outcome Measures :
  1. The rate of complications related to Inferior Vena Cava Filter use.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196118


Locations
Show Show 17 study locations
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Layout table for investigator information
Principal Investigator: Bob Smouse, MD Peoria Radiology Research & Education Foundation

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00196118    
Other Study ID Numbers: 04-507-01
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 11, 2007
Last Verified: December 2007
Keywords provided by Cook Group Incorporated:
Pulmonary Embolism
Venous Thromboembolism
Inferior Vena Cava Filter
IVC
PE
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Thromboembolism
Embolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases