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Excimer Laser Assisted IVC Filter Retrieval

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ClinicalTrials.gov Identifier: NCT02240251
Recruitment Status : Recruiting
First Posted : September 15, 2014
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Robert Lewandowski, 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.

Condition or disease Intervention/treatment
IVC Filters Other: Prospective Chart Review

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 : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval
Study Start Date : January 2012
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Group/Cohort Intervention/treatment
Patients undergoing IVC filter removal using the excimer laser
Laser Assisted IVC Filter Removal
Other: 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.

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anyone ages 18-100 years old that will undergo laser assisted IVC filter removal at Northwestern Memorial Hospital in Chicago IL USA

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240251

Contact: Jennifer Karp, RN BSN 312-926-5289 jkarp@nm.org
Contact: Robert Lewandowski, MD 312-695-9121 r-lewandowski@northwestern.edu

United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Jennifer Karp, RN BSN    312-926-5289    jkarp@nm.org   
Contact: Kush Desai, MD    312-926-5289    kdesai007@northwestern.edu   
Principal Investigator: Robert Lewandowski, MD         
Sub-Investigator: Kush Desai, MD         
Sub-Investigator: Mark Eskandari, MD         
Sponsors and Collaborators
Northwestern University
Principal Investigator: Robert Lewandowski, MD Northwestern University

Responsible Party: Robert Lewandowski, Primary Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT02240251     History of Changes
Other Study ID Numbers: NU STU 00058721
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by Robert Lewandowski, Northwestern University:
Inferior Vena Cava Filter
IVC Filter
IVC filter removal
Excimer Laser