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

Pulmonary Embolism Clinical Trial

Official title:

A Non-Randomized Prospective Study of IVC Filter Retrieval

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196118
• Other study ID #: 04-507-01
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 7, 2007
• Start date: April 2005
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Device:
• Günther Tulip Vena Cava Filter

Locations

Country	Name	City	State
United States	INOVA Alexandria	Alexandria	Virginia
United States	Atlanta Medical Center	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Chicago Hospital	Chicago	Illinois
United States	Spectrum Health Butterworth & Blodgett Campuses	Grand Rapids	Michigan
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute	Miami	Florida
United States	Christiana Hospital	Newark	Delaware
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Utah Valley Regional Medical Center Department of Radiology	Provo	Utah
United States	LDS Hospital: Department of Radiology	Salt Lake City	Utah
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful filter retrieval following implant.
Secondary	The rate of complications related to Inferior Vena Cava Filter use.