Forceps vs. Snare IVC Filter Removal

Prospective Comparison of Rigid Forceps Versus Endovascular Snare for Routine IVC Filter Retrieval

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.

Study Overview

• Status: Recruiting
• Conditions: DVT
• Intervention / Treatment: Device: IVC filter removal

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osmanuddin Ahmed, MD; Phone Number: 773-795-7226; Email: oahmed@uchicago.edu
• Study Contact Backup: Name: Pamela Lofton, RN, MSN; Phone Number: 773-702-2537

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • UChicago Medicine
      • Contact: Osmanuddin Ahmed, M.D.; Phone Number: 773-795-7226; Email: oahmed@uchicago.edu
      • Contact: Pamela Lofton, RN, MSN; Phone Number: 773-702-2537; Email: plofton@uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Forceps; 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; 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.
Active Comparator: Snare; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Osmanuddin Ahmed, MD, UChicago Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: IVC filter, filter removal, filter retrieval
• Other Study ID Numbers: IRB 18-1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No