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

Phase 4

Completed

• Conditions: Pulmonary Embolism; Venous Thromboembolism

• Registration Number: NCT00196118
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2007-07
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-07
• Last Update Posted: 2007-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The rate of successful filter retrieval following implant.

Secondary Outcome Measures

Name	Time	Method
The rate of complications related to Inferior Vena Cava Filter use.

Trial Locations

Locations (17)

Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute; 🇺🇸 Miami, Florida, United States

Atlanta Medical Center; 🇺🇸 Atlanta, Georgia, United States

OSF St. Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Oregon Health & Sciences University; 🇺🇸 Portland, Oregon, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

INOVA Alexandria; 🇺🇸 Alexandria, Virginia, United States

LDS Hospital: Department of Radiology; 🇺🇸 Salt Lake City, Utah, United States

Utah Valley Regional Medical Center Department of Radiology; 🇺🇸 Provo, Utah, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Spectrum Health Butterworth & Blodgett Campuses; 🇺🇸 Grand Rapids, Michigan, United States

University of Chicago Hospital; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Christiana Hospital; 🇺🇸 Newark, Delaware, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States