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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196118
First Posted: September 20, 2005
Last Update Posted: December 11, 2007
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.
Information provided by:
Cook Group Incorporated
  Purpose
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 Intervention Phase
Pulmonary Embolism Venous Thromboembolism Device: Günther Tulip Vena Cava Filter Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Non-Randomized Prospective Study of IVC Filter Retrieval

Further study details as provided by Cook Group Incorporated:

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

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

Estimated Enrollment: 800
Study Start Date: April 2005
Estimated Study Completion Date: July 2007
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute
Miami, Florida, United States, 33176
United States, Georgia
Atlanta Medical Center
Atlanta, Georgia, United States, 30312
United States, Illinois
University of Chicago Hospital
Chicago, Illinois, United States, 60637
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Spectrum Health Butterworth & Blodgett Campuses
Grand Rapids, Michigan, United States, 49503
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Utah
Utah Valley Regional Medical Center Department of Radiology
Provo, Utah, United States, 84605
LDS Hospital: Department of Radiology
Salt Lake City, Utah, United States, 84103
United States, Virginia
INOVA Alexandria
Alexandria, Virginia, United States, 22304
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Bob Smouse, MD Peoria Radiology Research & Education Foundation
  More Information

ClinicalTrials.gov Identifier: NCT00196118     History of Changes
Other Study ID Numbers: 04-507-01
First Submitted: September 12, 2005
First Posted: September 20, 2005
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:
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases