Excimer Laser Assisted IVC Filter Retrieval

NCT ID: NCT02240251

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

535 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-03

Study Completion Date

2022-11-11

Brief Summary

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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

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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.

Conditions

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IVC Filters

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing IVC filter removal using the excimer laser

Laser Assisted IVC Filter Removal

Prospective Chart Review

Intervention Type 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.

Interventions

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Prospective Chart Review

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Robert Lewandowski

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Lewandowski, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NU STU 00058721

Identifier Type: -

Identifier Source: org_study_id

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