Excimer Laser Assisted IVC Filter Retrieval

Completed

• Conditions: IVC Filters
• Interventions: Other: Prospective Chart Review

• Registration Number: NCT02240251
• Lead Sponsor: Northwestern University

Brief Summary

This is a prospective chart review to follow our laser-assisted IVC filter retrieval patients. We intend to validate existing literature and scientific findings by publishing our own clinical experience in difficult IVC filter retrievals.

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 Timeline

• Study Start: 2012-01-03
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

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.

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Exclusion Criteria

• Patients who refuse the use of the excimer laser device to attempt to remove their IVC filter.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing IVC filter removal using the excimer laser	Prospective Chart Review	Laser Assisted IVC Filter Removal

Primary Outcome Measures

Name	Time	Method
Evaluate any adverse events related to laser assisted IVC filter removal	up to 1 year after Laser Assited IVC filter removal	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.
Effectiveness of Laser Assisted IVC filter removal	At time of IVC filter removal	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.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States