100 Participants Needed

Forceps vs. Snare for IVC Filter Removal in Deep Vein Thrombosis

OA
PL
Overseen ByPamela Lofton, RN, MSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for removing IVC filters, which catch blood clots in the legs before they reach the lungs. The researchers aim to determine whether an endovascular snare (a device like a lasso) or rigid forceps (similar to tweezers) is more effective, based on success rates and procedure time. Individuals who have had an IVC filter implanted within the last 6 months, specifically the Cook Celect or Argon Medical Option Elite types, and are referred for removal might be suitable for this trial. As an unphased study, this trial allows participants to contribute to advancements in IVC filter removal techniques.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves a medical procedure, it's best to discuss your medications with the trial team or your doctor.

What prior data suggests that these methods for IVC filter removal are safe?

Research has shown that both the snare and forceps methods for removing IVC filters are generally safe. Studies indicate that the snare method has a high success rate of about 97.9%, with complications in 6.0% of cases. This means almost all filters were removed successfully, with only a few issues.

The forceps method is also considered safe. Reports show that the success rate for removing filters ranges from 81% to 100%, depending on the situation. In one study, forceps successfully removed filters in 58 out of 60 patients.

Both methods are well-tolerated by patients, with few reports of serious problems. This is reassuring for those considering participation in a clinical trial involving these procedures.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different techniques for removing IVC filters in patients with deep vein thrombosis, which could improve patient outcomes. The use of a snare device, which acts like a lasso to capture the filter, offers a more flexible approach that might reduce trauma during removal. On the other hand, the forceps technique directly engages the filter apex, providing a potentially more precise removal. Understanding the benefits and drawbacks of each method could lead to better, more tailored interventions for patients needing IVC filter removal, ultimately enhancing safety and effectiveness.

What evidence suggests that the snare and forceps methods are effective for IVC filter removal?

This trial will compare two methods for IVC filter removal: using a snare and using forceps. Studies have shown that removing IVC filters with a snare is quite effective. One study found a 97.9% success rate for snare removal, with complications occurring in only 6% of cases. Another study showed a slightly lower success rate of 92% for retrievable filters.

Using forceps to remove IVC filters also proves effective. Research indicates a 99.05% success rate with forceps, although there is a higher chance of complications. Forceps have successfully removed difficult, embedded filters in many cases. Both methods are promising, but the choice may depend on the specific needs of the patient and the condition of the filter. Participants in this trial will be randomized to receive either the snare or forceps method for IVC filter removal.12356

Who Is on the Research Team?

OA

Osmanuddin Ahmed, M.D.

Principal Investigator

UChicago Medicine

Are You a Good Fit for This Trial?

Adults over 18 needing an IVC filter removal, specifically those with Cook Celect or Argon Medical Option Elite filters implanted for less than 6 months at UCMC. Excludes pregnant women, individuals with clotting disorders, prior filter procedures, central venous occlusion, or coagulopathy.

Inclusion Criteria

I am not pregnant.
I am referred for a procedure to remove an IVC filter.
I'm sorry, but this criterion seems incomplete and does not provide enough information to be summarized. Could you please provide more context or detail so that I can better assist you?
See 1 more

Exclusion Criteria

Patients with outside hospital filter placement
You have had an implant in your body for more than 6 months.
Only Cook Celect or Argon Medical Option Elite filters are allowed.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

IVC filter removal using either endovascular snare or rigid forceps

1 day
1 visit (in-person)

Immediate Post-Procedure Monitoring

Patients monitored for 2-4 hours in the interventional radiology recovery area for complications

2-4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
1 visit (in-person), 1 call (telephone)

What Are the Treatments Tested in This Trial?

Interventions

  • IVC filter removal
Trial Overview The trial is comparing two common methods of IVC filter removal: using an endovascular snare device versus rigid forceps. The study aims to determine which method has higher success rates and shorter procedure times.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: SnareActive Control1 Intervention
Group II: ForcepsActive Control1 Intervention

IVC filter removal is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as IVC filter removal for:
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Approved in European Union as IVC filter removal for:
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Approved in Canada as IVC filter removal for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Published Research Related to This Trial

In a study of 60 patients, rigid endobronchial forceps-assisted retrieval of inferior vena cava (IVC) filters achieved a high success rate of 96.7%, demonstrating its effectiveness when standard retrieval methods fail.
The use of forceps was associated with minimal complications, with only four significant issues reported, suggesting that this technique is both safe and reliable for removing problematic IVC filters.
Endobronchial forceps-assisted complex retrieval of inferior vena cava filters.Tavri, S., Patel, IJ., Kavali, P., et al.[2020]
In a study of 536 IVC filter retrievals, the overall success rate was very high at 97.9%, with standard snare techniques achieving a success rate of 99.4% and advanced forceps techniques at 98.8%.
While the endobronchial forceps technique had a higher complication rate (14.5%) compared to the standard snare technique (1.7%), this was attributed to longer dwell times and challenges with non-retrievable filters, indicating that forceps can still be a safe and effective option for difficult retrieval cases.
Safety and efficacy of inferior vena cava filter retrieval: a 5-year single center retrospective review from a tertiary care center.Schuchardt, P., Kis, L., Goloubev, A., et al.[2022]
The rigid forceps technique for removing severely tilted and embedded inferior vena cava (IVC) filters achieved an 85% success rate in a study of 13 cases over 22 months, demonstrating its effectiveness in challenging retrieval situations.
No major complications were reported during the procedure, indicating that this technique not only improves retrieval rates but also maintains a strong safety profile for patients with IVC filters.
Initial experience using the rigid forceps technique to remove wall-embedded IVC filters.Avery, A., Stephens, M., Redmond, K., et al.[2016]

Citations

Safety and efficacy of inferior vena cava filter retrievalFilter retrieval utilizing only forceps had a 99.05% (104/105) success rate, though it also exhibited a higher complication profile compared to ...
Clinical study Embedded Inferior Vena Cava Filter RemovalRigid endobronchial forceps were used successfully to remove 20 embedded IVC filters in 21 patients. There was one case of failure to remove an embedded ...
Inferior vena cava filter retrievals using advanced techniquesRegarding filters, 92.6% (702/758) were retrievable and 7.4% (56/758) were permanent. Indications for complex retrieval included the failure of standard ...
Successful retrieval of tip-embedded inferior vena cava ...We present a case study of two patients who underwent a successful tip-embedded IVC filter retrieval using a modified forceps technique, which has not been ...
Endobronchial forceps-assisted complex retrieval of ...Key Findings: In 60 consecutive patients, 58 inferior vena cava (IVC) filters were successfully retrieved with rigid endobronchial forceps; two ...
A retrospective two-center study assessing the safety and ...The technical success rate for retrieval reported in the literature ranges between 81% and 100%, with clinical success reported between 84.6% and 95.2%. Up to ...
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