Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter - Full Text View

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 IV

MedlinePlus related topics:

Pulmonary Embolism

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	A Non-Randomized Prospective Study of IVC Filter Retrieval

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
	OSF St. Francis Medical Center
	Peoria, Illinois, United States, 61637
	University of Chicago Hospital
	Chicago, Illinois, United States, 60637

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
	LDS Hospital: Department of Radiology
	Salt Lake City, Utah, United States, 84103
	Utah Valley Regional Medical Center Department of Radiology
	Provo, Utah, United States, 84605

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

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

Keywords provided by Cook:

Pulmonary Embolism

Venous Thromboembolism

Inferior Vena Cava Filter

IVC

PE

Study placed in the following topic categories:

Embolism and Thrombosis

Pulmonary Embolism

Respiratory Tract Diseases

Embolism

Lung Diseases

Vascular Diseases

Venous Thromboembolism

Thrombosis

Thromboembolism

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00196118