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

This study has been completed.
Sponsor:
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00196118
First received: September 12, 2005
Last updated: December 7, 2007
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Non-Randomized Prospective Study of IVC Filter Retrieval

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
Investigators
Principal Investigator: Bob Smouse, MD Peoria Radiology Research & Education Foundation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00196118     History of Changes
Other Study ID Numbers: 04-507-01
Study First Received: September 12, 2005
Last Updated: December 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Pulmonary Embolism
Venous Thromboembolism
Inferior Vena Cava Filter
IVC
PE

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 21, 2013