Forceps vs. Snare IVC Filter Removal

The University of Chicago

Status: Enrolling

Conditions: DVT

Treatments: Device: IVC filter removal

Study type: Interventional

Funder types: Other

Identifiers

NCT04092192

IRB 18-1502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Forceps

Active Comparator group

Description:

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.

Treatment:

Device: IVC filter removal

Snare

Active Comparator group

Description:

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.

Treatment:

Device: IVC filter removal