Forceps vs. Snare IVC Filter Removal

NCT04092192 | Recruiting DMC FDA Device

• 1 other identifier: IRB 18-1502
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

DVT

Keywords

IVC filter, filter removal, filter retrieval

Outcome Measures

Primary Outcomes (4)

• Removal success rate

  Data will be analyzed by a biostatistician to determine statistical differences between cohorts with respect to outcome measures.

  Procedure date

• 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.

  Procedure start to finish

• Costs

  Costs associated with filter removal encounter

  Date of procedure up through 6 months following IVC filter removal

• 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.

  Date of procedure through 6 months following IVC filter removal

Study Arms (2)

Forceps

ACTIVE COMPARATOR

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.

Device: IVC filter removal

Snare

ACTIVE COMPARATOR

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.

Device: IVC filter removal

Interventions

IVC filter removal DEVICE

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.

Forceps; Snare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

UChicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

Study Officials

• Osmanuddin Ahmed, MD

  UChicago Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osmanuddin Ahmed, MD

CONTACT

773-795-7226; oahmed@uchicago.edu

Pamela Lofton, RN, MSN

CONTACT

773-702-2537

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: December 26, 2018
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)