NCT Number: NCT00196118
Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Christiana Hospital, Newark, Delaware, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
The rate of successful filter retrieval following implant.
Secondary outcomes
-
The rate of complications related to Inferior Vena Cava Filter use.
Sponsors and collaborators
Lead sponsor
Cook Group Incorporated
Industry
Registry information
Official study title
A Non-Randomized Prospective Study of IVC Filter Retrieval
Important dates
- Study start
- 2005
- Study completion
- 2007
- First posted
- Sep 20, 2005
- Registry last updated
- Dec 11, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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