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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 7, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The rate of successful filter retrieval following implant.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00196118 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Non-Randomized Prospective Study of IVC Filter Retrieval

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Pulmonary Embolism
Venous Thromboembolism

Intervention ^ICMJE

Device: Günther Tulip Vena Cava Filter

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

800

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00196118

Responsible Party

Study ID Numbers ^ICMJE

04-507-01

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Bob Smouse, MD

Peoria Radiology Research & Education Foundation

Information Provided By

Cook

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP