Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE
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.
Interventions
DEVICEGünther Tulip Vena Cava Filter
Sponsors
Cook Group Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of successful filter retrieval following implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of complications related to Inferior Vena Cava Filter use. | — |
Countries
United States
Outcome results
None listed