What this study is
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.
What's being tested
- IVC filter removal
Intervention · 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.
Study details
- Official title
- Prospective Comparison of Rigid Forceps Versus Endovascular Snare for Routine IVC Filter Retrieval
- Sponsor
- University of Chicago
- Conditions
- DVT
- Enrolling
- 100 people
- Starts
- 2018-12-26
- Est. completion
- 2028-01-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUChicago Medicine
Chicago, Illinois, United States
- Osmanuddin Ahmed, M.D. · Contact773-795-7226oahmed@uchicago.edu
- Pamela Lofton, RN, MSN · Contact773-702-2537plofton@uchicago.edu
Recruiting
Study team
Sponsor
University of Chicago
Study ID IRB 18-1502
Principal investigator
Osmanuddin Ahmed, MD
UChicago Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.