Clinical trial NCT00196118: Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
Official title: A Non-Randomized Prospective Study of IVC Filter Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Embolism
Venous Thromboembolism
Keywords: Pulmonary Embolism
Venous Thromboembolism
Inferior Vena Cava Filter
IVC
PE
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: The rate of successful filter retrieval following implant.
Secondary outcomes:
measure: The rate of complications related to Inferior Vena Cava Filter use.
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth & Blodgett Campuses
state: Michigan
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Provo
country: United States
facility: Utah Valley Regional Medical Center Department of Radiology
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital: Department of Radiology
state: Utah
city: Alexandria
country: United States
facility: INOVA Alexandria
state: Virginia
Study officials:
affiliation: Peoria Radiology Research & Education Foundation
name: Bob Smouse, MD
role: PRINCIPAL_INVESTIGATOR
References: