Forceps vs. Snare IVC Filter Removal

DVT Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092192
• Other study ID #: IRB 18-1502
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: Osmanuddin Ahmed, MD
• Phone: 773-795-7226
• Email: oahmed[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• DVT

Intervention

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.

Locations

Country	Name	City	State
United States	UChicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal success rate	Data will be analyzed by a biostatistician to determine statistical differences between cohorts with respect to outcome measures.	Procedure date
Primary	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
Primary	Costs	Costs associated with filter removal encounter	Date of procedure up through 6 months following IVC filter removal
Primary	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