Excimer Laser Assisted IVC Filter Retrieval
A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval
Study Overview
Detailed Description
At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed >95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques.
Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will be consented to participate in the chart review study and become a part of a registry kept at Northwestern Memorial Hospital. The procedure itself is not being used as part of the study. Chart reviews will be completed and data collected on the procedure to remove the filter. Follow up after the procedure by phone call and chart review will be completed at least once, 1 week after the filter removal.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients will be male and female aged 18 years to 100 years old who were treated with either permanent or retrievable IVC filter placement and were referred to the Interventional Radiology or Vascular Surgery departments for IVC filter retrieval starting December 1, 2011.
- Patients have failed all other traditional methods/attempts at removal of their IVC filter.
Exclusion Criteria:
- Patients who refuse the use of the excimer laser device to attempt to remove their IVC filter.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients undergoing IVC filter removal using the excimer laser
Laser Assisted IVC Filter Removal
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The laser assisted IVC filter removal procedure itself is not part of this study.
This is a prospective chart review for patients undergoing this procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluate any adverse events related to laser assisted IVC filter removal
Time Frame: up to 1 year after Laser Assited IVC filter removal
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The number and severity of adverse events will be recorded to evaluate safety.
This will be conducted as a phone call to the patient 1 week after IVC filter removal and then as a chart review only.
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up to 1 year after Laser Assited IVC filter removal
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Effectiveness of Laser Assisted IVC filter removal
Time Frame: At time of IVC filter removal
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Success rate of removing IVC filters using the laser will be recorded.
If a filter cannot be removed with the laser the reason for this failure will be recorded.
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At time of IVC filter removal
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Lewandowski, MD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NU STU 00058721
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