Forceps vs. Snare IVC Filter Removal

Not Applicable

Recruiting

• Conditions: DVT
• Interventions: Device: IVC filter removal

• Registration Number: NCT04092192
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-12-26
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.
• Cook Celect filter or Argon Medical Option Elite

Exclusion Criteria

• 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)
• Clotting disorder
• Central venous occlusion
• Prior filter placement/removal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Snare	IVC filter removal	Subjects randomized to this cohort will have their IVC filter removed using an endovascular snare (like a lasso) device that is designed to catch the hook of the filter and allow it to be captured.
Forceps	IVC filter removal	Subjects randomized to this cohort will have their IVC filter removed using a rigid forceps device that will be used to engage the filter apex directly and allow for the filter to be capture/removed.

Primary Outcome Measures

Name	Time	Method
Procedure related complications	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.
Flouroscopy time	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.
Removal success rate	Procedure date	Data will be analyzed by a biostatistician to determine statistical differences between cohorts with respect to outcome measures.
Costs	Date of procedure up through 6 months following IVC filter removal	Costs associated with filter removal encounter

Trial Locations

Locations (1)

UChicago Medicine; 🇺🇸 Chicago, Illinois, United States