Forceps vs. Snare IVC Filter Removal
ConditionDVT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-pregnant females
Adult patients (age 18 years and older)
Referred to Interventional Radiology for IVC filter removal
IVC filter implanted less than 6 months with the procedure being performed at UCMC by current IR staff.
Disqualifiers
Patients with outside hospital filter placement
Filters other than Cook Celect or Argon Medical Option Elite
Implantation period >6 months
Evidence of coagulopathy (INR <1.8, platelet count >50k)
Trial design
Design model
Parallel
Treatments tested in this trial
IVC filter removal
DeviceIn 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ForcepsActive comparator 1 intervention
Group B: SnareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Removal success rate
Data will be analyzed by a biostatistician to determine statistical differences between cohorts with respect to outcome measures.
Time frame
Procedure date2
Flouroscopy time
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
Procedure start to finish3
Costs
Costs associated with filter removal encounter
Time frame
Date of procedure up through 6 months following IVC filter removal4
Procedure related complications
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.
Time frame
Date of procedure through 6 months following IVC filter removalSponsors and contacts
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Source ClinicalTrials.gov