<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02240251</url>
  </required_header>
  <id_info>
    <org_study_id>NU STU 00058721</org_study_id>
    <nct_id>NCT02240251</nct_id>
  </id_info>
  <brief_title>Excimer Laser Assisted IVC Filter Retrieval</brief_title>
  <official_title>A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective chart review to follow our laser-assisted IVC filter retrieval&#xD;
      patients. We intend to validate existing literature and scientific findings by publishing our&#xD;
      own clinical experience in difficult IVC filter retrievals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed&#xD;
      &gt;95%. Technical failures, although rare, are usually related to excessive endoluminal&#xD;
      scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques&#xD;
      are often employed in difficult cases. The excimer laser sheath has been successfully used at&#xD;
      Northwestern for patients who had failed all other retrieval techniques.&#xD;
&#xD;
      Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will&#xD;
      be consented to participate in the chart review study and become a part of a registry kept at&#xD;
      Northwestern Memorial Hospital. The procedure itself is not being used as part of the study.&#xD;
      Chart reviews will be completed and data collected on the procedure to remove the filter.&#xD;
      Follow up after the procedure by phone call and chart review will be completed at least once,&#xD;
      1 week after the filter removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2012</start_date>
  <completion_date type="Actual">November 11, 2022</completion_date>
  <primary_completion_date type="Actual">November 11, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Evaluate any adverse events related to laser assisted IVC filter removal</measure>
    <time_frame>up to 1 year after Laser Assited IVC filter removal</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of Laser Assisted IVC filter removal</measure>
    <time_frame>At time of IVC filter removal</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">535</enrollment>
  <condition>IVC Filters</condition>
  <arm_group>
    <arm_group_label>Patients undergoing IVC filter removal using the excimer laser</arm_group_label>
    <description>Laser Assisted IVC Filter Removal</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prospective Chart Review</intervention_name>
    <description>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.</description>
    <arm_group_label>Patients undergoing IVC filter removal using the excimer laser</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anyone ages 18-100 years old that will undergo laser assisted IVC filter removal at&#xD;
        Northwestern Memorial Hospital in Chicago IL USA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be male and female aged 18 years to 100 years old who were treated with&#xD;
             either permanent or retrievable IVC filter placement and were referred to the&#xD;
             Interventional Radiology or Vascular Surgery departments for IVC filter retrieval&#xD;
             starting December 1, 2011.&#xD;
&#xD;
          -  Patients have failed all other traditional methods/attempts at removal of their IVC&#xD;
             filter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse the use of the excimer laser device to attempt to remove their IVC&#xD;
             filter.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Lewandowski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Robert Lewandowski</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>Inferior Vena Cava Filter</keyword>
  <keyword>IVC Filter</keyword>
  <keyword>IVC filter removal</keyword>
  <keyword>Excimer Laser</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02240251
org study id: NU STU 00058721
nct id: NCT02240251
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Evaluate any adverse events related to laser assisted IVC filter removal
time frame: up to 1 year after Laser Assited IVC filter removal
description: 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.
measure: Effectiveness of Laser Assisted IVC filter removal
time frame: At time of IVC filter removal
description: 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.
arm group label: Patients undergoing IVC filter removal using the excimer laser
description: Laser Assisted IVC Filter Removal
intervention type: Other
intervention name: Prospective Chart Review
description: 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.
arm group label: Patients undergoing IVC filter removal using the excimer laser
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Robert Lewandowski, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Robert Lewandowski
investigator title: Primary Investigator