UChicago Medicine
Chicago, Illinois, 60637, United States
Location status: Recruiting
Location contact
Osmanuddin Ahmed, M.D.
CONTACT
Pamela Lofton, RN, MSN
CONTACT
NCT Number: NCT04092192
IVC filters are mechanical filters placed in a patient's body to trap blood clots in the legs migrating to the lungs. When no longer indicated, interventional radiologists are consulted for IVC filter removal. Currently, many methods for extracting IVC filters exist. Two of the most common methods involve using an endovascular snare device or rigid forceps. We intend to prospectively compare these two methods in an attempt to see if one offers an advantage to the other. This will be compared by evaluating success rates and procedure time.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60637, United States
Location status: Recruiting
Osmanuddin Ahmed, M.D.
CONTACT
Pamela Lofton, RN, MSN
CONTACT
Currently the optimal method for IVC filter retrieval with respect to success rate and fluoroscopic time (i.e. radiation exposure) is poorly understood. Both snare and forcep techniques have independently evaluated in literature but have never been compared directly. The proposed study would prospectively assess whether one of these established technique offers an advantage with respect to either of these variables.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the clinic, it will be explained to patient that they are asked to participate in a study that would randomize them to one of two established techniques for IVC filter removal. It will be explained these are both techniques that are used by interventional radiologists normally used for IVC filter retrieval.
One technique would be the utilization of an endovascular snare (like a lasso) device that is designed to catch the hook of the filter and allow it to be captured.
The other technique described will be the usage of a rigid forceps device that will be used to engage the filter apex directly and allow for the filter to be capture/removed.
Time frame: Procedure date
Data will be analyzed by a biostatistician to determine statistical differences between cohorts with respect to outcome measures.
Time frame: Procedure start to finish
Venography will be performed using a flush catheter and contrast material to evaluate for tip embedding. After filter retrieval, repeat venography will be performed to evaluate for thrombosis, caval spasm, caval perforation, fractured fragments, and other potential complications.
Time frame: Date of procedure up through 6 months following IVC filter removal
Costs associated with filter removal encounter
Time frame: Date of procedure through 6 months following IVC filter removal
After hemostasis is achieved, patients will be monitored for 2-4 hours in the interventional radiology recovery area.
One month after filter retrieval, patients will be seen in clinic for follow-up. During this visit, a physicial assessment will done, including adverse events and review of medications.
Six months after filter retrieval, patient will be contacted by telephone for follow-up. Adverse event and medication review will be performed during this call.
Contact information is provided by the study sponsor or research team.
Osmanuddin Ahmed, MD
CONTACT
Pamela Lofton, RN, MSN
CONTACT
University of Chicago
Other
Prospective Comparison of Rigid Forceps Versus Endovascular Snare for Routine IVC Filter Retrieval
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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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