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OpenTrials
Completed

NCT Number: NCT02240251

Excimer Laser Assisted IVC Filter Retrieval

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.

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prospective Chart Review

Other

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.

Primary outcomes

  1. Evaluate any adverse events related to laser assisted IVC filter removal

    Time frame: 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.

  2. Effectiveness of Laser Assisted IVC filter removal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Sep 15, 2014
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.