<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/NCT02201277</url>
  </required_header>
  <id_info>
    <org_study_id>UCSF 14-13307</org_study_id>
    <nct_id>NCT02201277</nct_id>
  </id_info>
  <brief_title>ODEN Trial: Option vs. Denali IVC Filters</brief_title>
  <acronym>ODEN</acronym>
  <official_title>Prospective Randomized Evaluation of the Denali and Option Inferior Vena Cava Filters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is a prospective randomized trial evaluating the relative safety of two&#xD;
      inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous&#xD;
      deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All&#xD;
      eligible patients will have been ordered to have a IVC filter placed by their primary medical&#xD;
      team and filters will be placed in these patients whether or not they wish to participate in&#xD;
      this trial as part of standard of care. The investigators will follow up with patients 30&#xD;
      days after IVC filter placement and ask them to come back for filter removal if medically&#xD;
      appropriate. If removal is not medically appropriate in 30 days, the investigators will&#xD;
      attempt to schedule removal every 30 days after initial placement.&#xD;
&#xD;
      Primary outcome measures will be IVC filter complications such as filter penetration through&#xD;
      the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots&#xD;
      formed within the filter. All of these are reported complications of all IVC filters.&#xD;
&#xD;
      The research also aims to improve the standard of care for IVC filter patient follow up as&#xD;
      the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon&#xD;
      as it is safe to do so.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The investigators hypothesize that there is no significant difference in efficacy and&#xD;
      complication rate between the Option and the Denali filter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized trial comparing two FDA-approved inferior vena cava&#xD;
      filters, the Denali retrievable IVC filter (Bard Peripheral Vascular Inc., Tempe, AZ) and the&#xD;
      Option Elite (Argon Medical, Athens, Texas).&#xD;
&#xD;
      Patients scheduled for IVC filter placement at UCSF Department of Interventional Radiology&#xD;
      (IR) will be asked by the IR physician performing the procedure at either UCSF Mt. Zion or&#xD;
      Moffitt hospital if they wish to participate in this prospective, randomized study.&#xD;
      Recruitment will be conducted by the physicians performing the IR procedures only. No&#xD;
      additional recruitment calls, emails, posters or web pages are necessary. All procedures and&#xD;
      the randomization to one of the two experimental groups will be carefully explained before&#xD;
      obtaining signed written consent.&#xD;
&#xD;
      Screening:&#xD;
&#xD;
      Screening will be conducted by the IR physician prior to the placement of the IVC filters.&#xD;
      Since this is a standard of care study, patients who are recommended for IVC filter placement&#xD;
      and are scheduled for the procedure are generally eligible.&#xD;
&#xD;
      The screening procedures are part of routine care before IVC filter placement and would be&#xD;
      done even if patients did not join the study.&#xD;
&#xD;
      The study doctor will review the results of most recent routine care imaging scans (CT or&#xD;
      MRI) of the abdomen and pelvis. This is done to confirm that the diameter of IVC is no wider&#xD;
      than 2.8cm. Both filters are FDA-approved to be placed in an IVC with maximal diameter of&#xD;
      2.8cm.&#xD;
&#xD;
      The study doctor will also review ultrasound of the lower extremity, when available, to&#xD;
      confirm that a blood clot was in fact present prior to performing the study. This ensures&#xD;
      that patients who present for IVC filter placement are screened properly.&#xD;
&#xD;
      The following screening procedures should be done within 12 days before the IVC filter&#xD;
      placement procedure as part of the standard of care.&#xD;
&#xD;
        -  A complete physical exam&#xD;
&#xD;
        -  The study doctor will ask about medical history and how well patient is able to do daily&#xD;
           activities&#xD;
&#xD;
        -  Routine care blood tests (about 2 tablespoons) o This is to ensure that the INR and&#xD;
           platelet count of the patient is within the safe limits to perform an invasive&#xD;
           procedure.&#xD;
&#xD;
      After Enrollment:&#xD;
&#xD;
      If the screening procedures show that the patient is eligible and consents to take part in&#xD;
      the study, IVC filter placement will occur after randomization.&#xD;
&#xD;
      After enrollment, the following procedures will be done during the study: Just as with&#xD;
      screening, all of these procedures are part of regular IVC filter placement care.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Randomization will occur on the day of procedure or prior clinic visit with IR physician to&#xD;
      either the Denali or Option IVC filter. All IR attending physicians on the protocol are&#xD;
      familiar with placement of either filter type. Prior to opening study to accrual, 75 sealed&#xD;
      security envelopes with the word Denali printed on a card inside and 75 sealed security&#xD;
      envelopes with the word Option will be assembled by IR staff not involved in the research.&#xD;
      The envelopes will be mixed up and placed in a bag. Computerized randomization programs and&#xD;
      tables were considered but we feel the envelopes will work best as there may be limited time&#xD;
      after patient is consented and procedure begins. This is especially true as some filters are&#xD;
      placed emergently. Previous IR studies have used this randomization technique with great&#xD;
      success.&#xD;
&#xD;
      Filter Placement:&#xD;
&#xD;
      Placement of an IVC filter involves the insertion of a plastic tube (catheter) into a vein in&#xD;
      the neck. Some numbing medicine (Lidocaine) will be injected in the skin over the vein before&#xD;
      the catheter is inserted. Intravenous medications will be given to induce moderate sedation&#xD;
      (Fentanyl for analgesic and Versed for moderate sedation). Once the catheter has been placed&#xD;
      into the vein, it will be advanced into the IVC. Once in correct position, x-ray contrast&#xD;
      material (x-ray dye-Omnipaque 350) will be injected through the catheter and x-ray pictures&#xD;
      taken. A series of x-ray pictures will be obtained of the IVC. These pictures are taken as&#xD;
      part of standard of care to determine the position of the renal veins with respect to the&#xD;
      IVC. The top of the filter must sit below the renal veins so it does not cause obstruction of&#xD;
      the renal veins. In addition, pictures of the IVC are taken to serve as another tool in&#xD;
      measuring the diameter of the IVC to make sure the diameter of the IVC is less than 2.8cm.&#xD;
      This is particularly important in situations when a CT or MRI of the abdomen and pelvis is&#xD;
      not available to have reviewed prior to the procedure. Once pictures are obtained and it is&#xD;
      made certain that the IVC diameter is less than 2.8cm, the filter will be inserted through&#xD;
      the catheter, and placed below the renal veins. During the placement procedure, positioning&#xD;
      of the filter will be monitored with x-ray pictures. At the completion of the procedure the&#xD;
      catheter will be removed and pressure will be applied to the insertion site until the&#xD;
      bleeding has stopped. All of this is part of routine standard of care for placement of the&#xD;
      filter. The doctor performing the procedure will be asked to complete a short questionnaire&#xD;
      after IVC filter placement which will be attached to &quot;Study Documents&quot;.&#xD;
&#xD;
      Follow-Up:&#xD;
&#xD;
      After the IVC filter placement procedure patient status will be followed by the&#xD;
      interventional radiology doctors.&#xD;
&#xD;
      Per standard of care after IVC filter placement, patient will be monitored in the hospital&#xD;
      for up to 1 hour after the procedure. If patient is in stable condition and sedation has&#xD;
      resolved, they will return home the same day or returned to their hospital rooms.&#xD;
&#xD;
      A tentative appointment for follow up and filter retrieval will be ordered by IR physician at&#xD;
      time of filter placement in APEX. This will ensure that scheduling and study staff will be&#xD;
      aware that further patient and primary care follow-up is required.&#xD;
&#xD;
      Patient primary care physician and/or relevant medical staff will be telephoned one month&#xD;
      after IVC filter placement to determine if patient is medically stable and suitable for IVC&#xD;
      filter removal.&#xD;
&#xD;
      If IR and other doctors agree that IVC filter removal is recommended, patient will be&#xD;
      scheduled to return for follow-up imaging and filter retrieval. If patient is not medically&#xD;
      stable or still at high risk for blood clots, we will attempt to schedule a follow up one&#xD;
      month later. Close contact with primary physician and patient will be maintained to ensure&#xD;
      that filter is removed as soon as possible. APEX scheduling will be used to make sure follow&#xD;
      up is performed at regular intervals.&#xD;
&#xD;
      At follow-up appointment these routine tests per standard of care before IVC filter removal&#xD;
      will be performed:&#xD;
&#xD;
        -  A physical exam&#xD;
&#xD;
        -  The study doctor will ask about medical history, how well patient is able to do daily&#xD;
           activities, and if they are experiencing any possible symptoms related to the IVC filter&#xD;
           placement such as abdominal or back pain.&#xD;
&#xD;
        -  A rotation CT focused to the site of the filter will be performed as part of routine&#xD;
           practice of filter removal. This is done to ensure the filter has not migrated or that&#xD;
           the filter has not penetrated through the walls of the IVC such that filter retrieval&#xD;
           would be unsafe.&#xD;
&#xD;
        -  IR physician will determine if patient status is stable and safe for IVC filter removal.&#xD;
           If not, physician will discuss with primary care doctor if filter needs to remain&#xD;
           permanently in patient or if later retrieval should be considered at subsequent follow&#xD;
           up visits.&#xD;
&#xD;
        -  IVC filter retrieval will be performed under moderate sedation. This procedure is very&#xD;
           similar in nature to the filter placement procedure. The IVC filter is removed via a&#xD;
           similar process to the way in which it was placed. X-ray dye (contrast) will be injected&#xD;
           around the filter to assure that the filter and the area beneath the filter are free of&#xD;
           blood clots and that it is safe to proceed with removal. A catheter-based snare will be&#xD;
           used to engage the hook at the end of the filter and the filter will then be enveloped&#xD;
           by a removal sheath and removed from the body.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    ODEN trial stopped due to low enrollment &amp; to focus on the PRESERVE Trial.&#xD;
  </why_stopped>
  <start_date type="Actual">May 27, 2014</start_date>
  <completion_date type="Actual">April 27, 2018</completion_date>
  <primary_completion_date type="Actual">April 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>analysis of the imaging data will be masked and filter type and PHI will be redacted so the radiologist assessor will not know which patients receive either the option or denali..</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>IVC: Filter Penetration</measure>
    <time_frame>in dwelling time in 1 day after filter insertion up to 3 years.</time_frame>
    <description>Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Computerized Tomography (CT) Studies With IVC Penetration</measure>
    <time_frame>0-1733 days</time_frame>
    <description>All CT studies with IVC penetration ≥ 3 mm, (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With IVC Filter Migration</measure>
    <time_frame>30 days</time_frame>
    <description>The number of participants with IVC filter migration in terms of distance migrated from initial placement location 30 days after filter placement will be assessed radiographically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVC Filter Tilt</measure>
    <time_frame>0-365 days post placement until project closure or patient endpoint reached</time_frame>
    <description>number of participants with tilt of greater than 15 degrees in any CT imaging studies after filter placement and before removal of filter or study endpoint reached.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVC Filter Fracture</measure>
    <time_frame>30 days</time_frame>
    <description>Fracture of the component legs and struts of the IVC filter will be determined radiographically 30 days after placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVC Filter Clot</measure>
    <time_frame>30 days</time_frame>
    <description>Thrombus (or clot) formed in the IVC filter 30 days after placement will be assessed radiographically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVC Filter Improved Patient Follow Up and Prompt Filter Removal</measure>
    <time_frame>Number of participants who had filters removed after 30 days up to 1 year</time_frame>
    <description>The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVC Filter Improved Patient Follow Up and Prompt Filter Removal: Number of Days</measure>
    <time_frame>Number of participants who had filters removed after 30 days up to 1 year</time_frame>
    <description>The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Denali</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Denali IVC Filter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Option</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Option Elite IVC Filter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filter Placed</intervention_name>
    <arm_group_label>Denali</arm_group_label>
    <arm_group_label>Option</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients scheduled for IVC filter placement at UCSF Moffitt, Mission Bay and Mount&#xD;
             Zion hospitals Interventional Radiology&#xD;
&#xD;
          2. 18+&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Necessity of permanent IVC filter.&#xD;
&#xD;
          2. Genetic or physical abnormalities of the inferior vena cava&#xD;
&#xD;
          3. Circumstances that in the opinion of the primary investigator, patient would be a poor&#xD;
             candidate either due to complications in medical condition or lack of ability for&#xD;
             follow up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen P Kohi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://radiology.ucsf.edu</url>
    <description>ucsf radiology home page</description>
  </link>
  <reference>
    <citation>Woodcock A, Campbell I, Collins JV, Hanson P, Harvey J, Corris P, Johnston ID. Bronchoscopy and infection control. Lancet. 1989 Jul 29;2(8657):270-1. doi: 10.1016/s0140-6736(89)90451-0. No abstract available.</citation>
    <PMID>2569071</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>April 16, 2019</results_first_submitted>
  <results_first_submitted_qc>August 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 12, 2019</results_first_posted>
  <last_update_submitted>August 22, 2019</last_update_submitted>
  <last_update_submitted_qc>August 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVC</keyword>
  <keyword>IVC Filter</keyword>
  <keyword>Filter</keyword>
  <keyword>Option</keyword>
  <keyword>Denali</keyword>
  <keyword>filter tilt</keyword>
  <keyword>filter migration</keyword>
  <keyword>filter fracture</keyword>
  <keyword>filter thrombus</keyword>
  <keyword>filter penetration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan: IRB Application</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 23, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02201277/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 23, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02201277/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: NCT02201277 References</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 23, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02201277/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From April 2014-May 2016, patients coming to University of California, San Francisco Interventional Radiology (IR) with a MD referral for an Inferior Vena Cava (IVC) filter were invited to join a study of two FDA approved filters. After informed consent, subjects were randomized 1:1 to receive either a Denali or Option Elite filter.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Denali</title>
          <description>Denali brand IVC Filter will be placed in patients randomized to Denali Arm.</description>
        </group>
        <group group_id="P2">
          <title>Option Elite</title>
          <description>Option Elite brand IVC Filter will be placed in patients randomized to Option Arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24">24 patients were consented but 1 patient had denali filter placed twice.</participants>
                <participants group_id="P2" count="21">1 patient was withdrawn after signing consent due to physician preference for the option filter.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Filter Retrieval</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Signed ICF But Did Not Enroll</title>
              <participants_list>
                <participants group_id="P1" count="0">Physician had preference for a specific filter so patient not randomized.</participants>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Filter Ruled to be Permanent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Lost to Follow up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Death (Before Removal)</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Complicated Retrieval</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Failed Retrieval (Referred Elsewhere)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failed retrieval</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>45 participants signed consent forms in the trial however one was withdrawn from the Option group due to physician's choice and in the Denali group one participant had two filters placed at different times.</population>
      <group_list>
        <group group_id="B1">
          <title>Denali</title>
          <description>Denali brand IVC Filter will be placed in patients randomized to Denali Arm.</description>
        </group>
        <group group_id="B2">
          <title>Option</title>
          <description>Option Elite IVC Filter brand IVC Filter will be placed in patients randomized to Option Arm.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="45"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>filters</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>age at enrollment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>*one male was not randomized</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Indication for filter placement</title>
          <description>In addition to known venous thromboembolism (VTE)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>VTE and contraindication to anticoagulation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prophylactic (no current thromboembolic disease)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failure to maintain anti coagulation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Recurrent Pulmonary Embolism Despite Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Complication from Anti coagulation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Filter Indwelling Time</title>
          <units>days since filter placement</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>filters</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="378.7" lower_limit="0" upper_limit="1647"/>
                    <measurement group_id="B2" value="277.1" lower_limit="0" upper_limit="1733"/>
                    <measurement group_id="B3" value="331.3" lower_limit="0" upper_limit="1733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>IVC: Filter Penetration</title>
        <description>Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.</description>
        <time_frame>in dwelling time in 1 day after filter insertion up to 3 years.</time_frame>
        <population>patients consented to the trial and needing a temporary ivc filter</population>
        <group_list>
          <group group_id="O1">
            <title>Denali</title>
            <description>Denali filter randomized participants</description>
          </group>
          <group group_id="O2">
            <title>Option</title>
            <description>Option filter randomized participants</description>
          </group>
        </group_list>
        <measure>
          <title>IVC: Filter Penetration</title>
          <description>Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.</description>
          <population>patients consented to the trial and needing a temporary ivc filter</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Fisher's exact test was used to determine if there was a difference in the numbers of filters with penetration for each type. The numbers were not powered enough to make extensive tests in this area meaningful.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>rate of penetration</non_inferiority_desc>
            <p_value>1.0</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Computerized Tomography (CT) Studies With IVC Penetration</title>
        <description>All CT studies with IVC penetration ≥ 3 mm, (%)</description>
        <time_frame>0-1733 days</time_frame>
        <population>Imaging was analyzed to see if filter penetration could be observed and there was some penetration on imaging but nothing beyond 3mm.</population>
        <group_list>
          <group group_id="O1">
            <title>Denali</title>
            <description>Denali filter randomized participants</description>
          </group>
          <group group_id="O2">
            <title>Option</title>
            <description>Option filter randomized participants</description>
          </group>
        </group_list>
        <measure>
          <title>Computerized Tomography (CT) Studies With IVC Penetration</title>
          <description>All CT studies with IVC penetration ≥ 3 mm, (%)</description>
          <population>Imaging was analyzed to see if filter penetration could be observed and there was some penetration on imaging but nothing beyond 3mm.</population>
          <units>Penetrating filter struts</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With IVC Filter Migration</title>
        <description>The number of participants with IVC filter migration in terms of distance migrated from initial placement location 30 days after filter placement will be assessed radiographically.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Denali</title>
            <description>Denali filter randomized participants</description>
          </group>
          <group group_id="O2">
            <title>Option</title>
            <description>Option filter randomized participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With IVC Filter Migration</title>
          <description>The number of participants with IVC filter migration in terms of distance migrated from initial placement location 30 days after filter placement will be assessed radiographically.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVC Filter Tilt</title>
        <description>number of participants with tilt of greater than 15 degrees in any CT imaging studies after filter placement and before removal of filter or study endpoint reached.</description>
        <time_frame>0-365 days post placement until project closure or patient endpoint reached</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Denali Filter Tilt</title>
            <description># of participants with tilt greater than or equal to 15 degrees</description>
          </group>
          <group group_id="O2">
            <title>Option Filter Tilt</title>
            <description># of participants with tilt greater than or equal to 15 degrees</description>
          </group>
        </group_list>
        <measure>
          <title>IVC Filter Tilt</title>
          <description>number of participants with tilt of greater than 15 degrees in any CT imaging studies after filter placement and before removal of filter or study endpoint reached.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVC Filter Fracture</title>
        <description>Fracture of the component legs and struts of the IVC filter will be determined radiographically 30 days after placement.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Denali</title>
            <description>Denali filter randomized participants</description>
          </group>
          <group group_id="O2">
            <title>Option</title>
            <description>Option filter randomized participants</description>
          </group>
        </group_list>
        <measure>
          <title>IVC Filter Fracture</title>
          <description>Fracture of the component legs and struts of the IVC filter will be determined radiographically 30 days after placement.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVC Filter Clot</title>
        <description>Thrombus (or clot) formed in the IVC filter 30 days after placement will be assessed radiographically.</description>
        <time_frame>30 days</time_frame>
        <population>the population sample size was not large enough to see differences between groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Denali</title>
            <description>Denali filter randomized participants</description>
          </group>
          <group group_id="O2">
            <title>Option</title>
            <description>Option filter randomized participants</description>
          </group>
        </group_list>
        <measure>
          <title>IVC Filter Clot</title>
          <description>Thrombus (or clot) formed in the IVC filter 30 days after placement will be assessed radiographically.</description>
          <population>the population sample size was not large enough to see differences between groups.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVC Filter Improved Patient Follow Up and Prompt Filter Removal</title>
        <description>The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.</description>
        <time_frame>Number of participants who had filters removed after 30 days up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Denali</title>
            <description>Denali IVC Filter&#xD;
Filters retrieved %</description>
          </group>
          <group group_id="O2">
            <title>Option</title>
            <description>Option Elite IVC Filter&#xD;
Filter retrieved %</description>
          </group>
        </group_list>
        <measure>
          <title>IVC Filter Improved Patient Follow Up and Prompt Filter Removal</title>
          <description>The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.</description>
          <units>Filter</units>
          <param>Number</param>
          <units_analyzed>Filter</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Filter</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVC Filter Improved Patient Follow Up and Prompt Filter Removal: Number of Days</title>
        <description>The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.</description>
        <time_frame>Number of participants who had filters removed after 30 days up to 1 year</time_frame>
        <population>Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Denali</title>
            <description>Denali IVC Filter&#xD;
Filters retrieved %</description>
          </group>
          <group group_id="O2">
            <title>Option</title>
            <description>Option Elite IVC Filter&#xD;
Filter retrieved %</description>
          </group>
        </group_list>
        <measure>
          <title>IVC Filter Improved Patient Follow Up and Prompt Filter Removal: Number of Days</title>
          <description>The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.</description>
          <population>Participants</population>
          <units>Days</units>
          <param>Number</param>
          <units_analyzed>Filter</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Filter</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161.7"/>
                    <measurement group_id="O2" value="130.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse events. For 30 days after removal of IVC filter or until study endpoint reached, patients will be followed for any adverse event that could be related to the IVC filter or removal.</time_frame>
      <desc>All adverse events (AE) attributed to the IVC filter device will be recorded until resolved or the AE is assessed as:&#xD;
stable&#xD;
new therapy started&#xD;
patient lost to follow-up&#xD;
withdraws&#xD;
death&#xD;
All serious adverse events (SAE) related to trial-related procedures will be followed until a final outcome &amp; resolution date is documented. If, after follow-up, return to baseline status or stabilization cannot be established before study exit an explanation should be recorded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Denali</title>
          <description>Denali brand IVC Filter will be placed in patients randomized to Denali Arm.&#xD;
24 enrolled</description>
        </group>
        <group group_id="E2">
          <title>Option</title>
          <description>Option brand IVC Filter will be placed in patients randomized to Option Arm.&#xD;
22 enrolled 1 withdrawn by investigator after consent before randomization and 1 patient had 2 filters placed.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>SIR Guidelines 2011</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Filters with IVC penetration ≥ 3 mm</sub_title>
                <description># of filters placed with IVC penetration by hook or strut greater than or equal to 3mm</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>All CTs with IVC penetration</sub_title>
                <description># of CTs with IVC penetration greater than or equal to 3 mm.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Filter Fracture</sub_title>
                <description>Filter fracture is any loss of a filter's structural integrity (ie, breakage or separation) documented by imaging or at autopsy</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Filter movement</sub_title>
                <description>Filter movement is a change in filter position compared with its deployed position (cranial or caudal) of more than 2 cm as documented by plain radiography, CT, or venography.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Filter Tilt &gt; or = 15 deg.</sub_title>
                <description>Patients with tilt greater than or equal to 15 degrees on greater than or equal to 1 CT study</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>All CT studies with Tilt</sub_title>
                <description>All CT studies with tilted filters greater than or equal to 15 degrees</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The ODEN trial was initially powered to observe differences between the two filter types after 75 of each filter were to be placed. Due to the opening of the PRESERVE trial and slightly lower than expected enrollment, the trial was terminated early.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Maureen Kohi, MD</name_or_title>
      <organization>University of California, San Francisco, Interventional Radiology</organization>
      <phone>(415) 353-1300</phone>
      <email>maureen.kohi@ucsf.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02201277
org study id: UCSF 14-13307
nct id: NCT02201277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This research study is a prospective randomized trial evaluating the relative safety of two
      inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous
      deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All
      eligible patients will have been ordered to have a IVC filter placed by their primary medical
      team and filters will be placed in these patients whether or not they wish to participate in
      this trial as part of standard of care. The investigators will follow up with patients 30
      days after IVC filter placement and ask them to come back for filter removal if medically
      appropriate. If removal is not medically appropriate in 30 days, the investigators will
      attempt to schedule removal every 30 days after initial placement.

      Primary outcome measures will be IVC filter complications such as filter penetration through
      the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots
      formed within the filter. All of these are reported complications of all IVC filters.

      The research also aims to improve the standard of care for IVC filter patient follow up as
      the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon
      as it is safe to do so.

      Hypothesis:

      The investigators hypothesize that there is no significant difference in efficacy and
      complication rate between the Option and the Denali filter.
This is a prospective, randomized trial comparing two FDA-approved inferior vena cava
      filters, the Denali retrievable IVC filter (Bard Peripheral Vascular Inc., Tempe, AZ) and the
      Option Elite (Argon Medical, Athens, Texas).

      Patients scheduled for IVC filter placement at UCSF Department of Interventional Radiology
      (IR) will be asked by the IR physician performing the procedure at either UCSF Mt. Zion or
      Moffitt hospital if they wish to participate in this prospective, randomized study.
      Recruitment will be conducted by the physicians performing the IR procedures only. No
      additional recruitment calls, emails, posters or web pages are necessary. All procedures and
      the randomization to one of the two experimental groups will be carefully explained before
      obtaining signed written consent.

      Screening:

      Screening will be conducted by the IR physician prior to the placement of the IVC filters.
      Since this is a standard of care study, patients who are recommended for IVC filter placement
      and are scheduled for the procedure are generally eligible.

      The screening procedures are part of routine care before IVC filter placement and would be
      done even if patients did not join the study.

      The study doctor will review the results of most recent routine care imaging scans (CT or
      MRI) of the abdomen and pelvis. This is done to confirm that the diameter of IVC is no wider
      than 2.8cm. Both filters are FDA-approved to be placed in an IVC with maximal diameter of
      2.8cm.

      The study doctor will also review ultrasound of the lower extremity, when available, to
      confirm that a blood clot was in fact present prior to performing the study. This ensures
      that patients who present for IVC filter placement are screened properly.

      The following screening procedures should be done within 12 days before the IVC filter
      placement procedure as part of the standard of care.

        -  A complete physical exam

        -  The study doctor will ask about medical history and how well patient is able to do daily
           activities

        -  Routine care blood tests (about 2 tablespoons) o This is to ensure that the INR and
           platelet count of the patient is within the safe limits to perform an invasive
           procedure.

      After Enrollment:

      If the screening procedures show that the patient is eligible and consents to take part in
      the study, IVC filter placement will occur after randomization.

      After enrollment, the following procedures will be done during the study: Just as with
      screening, all of these procedures are part of regular IVC filter placement care.

      Randomization:

      Randomization will occur on the day of procedure or prior clinic visit with IR physician to
      either the Denali or Option IVC filter. All IR attending physicians on the protocol are
      familiar with placement of either filter type. Prior to opening study to accrual, 75 sealed
      security envelopes with the word Denali printed on a card inside and 75 sealed security
      envelopes with the word Option will be assembled by IR staff not involved in the research.
      The envelopes will be mixed up and placed in a bag. Computerized randomization programs and
      tables were considered but we feel the envelopes will work best as there may be limited time
      after patient is consented and procedure begins. This is especially true as some filters are
      placed emergently. Previous IR studies have used this randomization technique with great
      success.

      Filter Placement:

      Placement of an IVC filter involves the insertion of a plastic tube (catheter) into a vein in
      the neck. Some numbing medicine (Lidocaine) will be injected in the skin over the vein before
      the catheter is inserted. Intravenous medications will be given to induce moderate sedation
      (Fentanyl for analgesic and Versed for moderate sedation). Once the catheter has been placed
      into the vein, it will be advanced into the IVC. Once in correct position, x-ray contrast
      material (x-ray dye-Omnipaque 350) will be injected through the catheter and x-ray pictures
      taken. A series of x-ray pictures will be obtained of the IVC. These pictures are taken as
      part of standard of care to determine the position of the renal veins with respect to the
      IVC. The top of the filter must sit below the renal veins so it does not cause obstruction of
      the renal veins. In addition, pictures of the IVC are taken to serve as another tool in
      measuring the diameter of the IVC to make sure the diameter of the IVC is less than 2.8cm.
      This is particularly important in situations when a CT or MRI of the abdomen and pelvis is
      not available to have reviewed prior to the procedure. Once pictures are obtained and it is
      made certain that the IVC diameter is less than 2.8cm, the filter will be inserted through
      the catheter, and placed below the renal veins. During the placement procedure, positioning
      of the filter will be monitored with x-ray pictures. At the completion of the procedure the
      catheter will be removed and pressure will be applied to the insertion site until the
      bleeding has stopped. All of this is part of routine standard of care for placement of the
      filter. The doctor performing the procedure will be asked to complete a short questionnaire
      after IVC filter placement which will be attached to "Study Documents".

      Follow-Up:

      After the IVC filter placement procedure patient status will be followed by the
      interventional radiology doctors.

      Per standard of care after IVC filter placement, patient will be monitored in the hospital
      for up to 1 hour after the procedure. If patient is in stable condition and sedation has
      resolved, they will return home the same day or returned to their hospital rooms.

      A tentative appointment for follow up and filter retrieval will be ordered by IR physician at
      time of filter placement in APEX. This will ensure that scheduling and study staff will be
      aware that further patient and primary care follow-up is required.

      Patient primary care physician and/or relevant medical staff will be telephoned one month
      after IVC filter placement to determine if patient is medically stable and suitable for IVC
      filter removal.

      If IR and other doctors agree that IVC filter removal is recommended, patient will be
      scheduled to return for follow-up imaging and filter retrieval. If patient is not medically
      stable or still at high risk for blood clots, we will attempt to schedule a follow up one
      month later. Close contact with primary physician and patient will be maintained to ensure
      that filter is removed as soon as possible. APEX scheduling will be used to make sure follow
      up is performed at regular intervals.

      At follow-up appointment these routine tests per standard of care before IVC filter removal
      will be performed:

        -  A physical exam

        -  The study doctor will ask about medical history, how well patient is able to do daily
           activities, and if they are experiencing any possible symptoms related to the IVC filter
           placement such as abdominal or back pain.

        -  A rotation CT focused to the site of the filter will be performed as part of routine
           practice of filter removal. This is done to ensure the filter has not migrated or that
           the filter has not penetrated through the walls of the IVC such that filter retrieval
           would be unsafe.

        -  IR physician will determine if patient status is stable and safe for IVC filter removal.
           If not, physician will discuss with primary care doctor if filter needs to remain
           permanently in patient or if later retrieval should be considered at subsequent follow
           up visits.

        -  IVC filter retrieval will be performed under moderate sedation. This procedure is very
           similar in nature to the filter placement procedure. The IVC filter is removed via a
           similar process to the way in which it was placed. X-ray dye (contrast) will be injected
           around the filter to assure that the filter and the area beneath the filter are free of
           blood clots and that it is safe to proceed with removal. A catheter-based snare will be
           used to engage the hook at the end of the filter and the filter will then be enveloped
           by a removal sheath and removed from the body.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: analysis of the imaging data will be masked and filter type and PHI will be redacted so the radiologist assessor will not know which patients receive either the option or denali..
measure: IVC: Filter Penetration
time frame: in dwelling time in 1 day after filter insertion up to 3 years.
description: Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.
measure: Computerized Tomography (CT) Studies With IVC Penetration
time frame: 0-1733 days
description: All CT studies with IVC penetration ≥ 3 mm, (%)
measure: Number of Participants With IVC Filter Migration
time frame: 30 days
description: The number of participants with IVC filter migration in terms of distance migrated from initial placement location 30 days after filter placement will be assessed radiographically.
measure: IVC Filter Tilt
time frame: 0-365 days post placement until project closure or patient endpoint reached
description: number of participants with tilt of greater than 15 degrees in any CT imaging studies after filter placement and before removal of filter or study endpoint reached.
measure: IVC Filter Fracture
time frame: 30 days
description: Fracture of the component legs and struts of the IVC filter will be determined radiographically 30 days after placement.
measure: IVC Filter Clot
time frame: 30 days
description: Thrombus (or clot) formed in the IVC filter 30 days after placement will be assessed radiographically.
measure: IVC Filter Improved Patient Follow Up and Prompt Filter Removal
time frame: Number of participants who had filters removed after 30 days up to 1 year
description: The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.
measure: IVC Filter Improved Patient Follow Up and Prompt Filter Removal: Number of Days
time frame: Number of participants who had filters removed after 30 days up to 1 year
description: The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.
arm group label: Denali
arm group type: Experimental
description: Denali IVC Filter
arm group label: Option
arm group type: Experimental
description: Option Elite IVC Filter
intervention type: Device
intervention name: Filter Placed
arm group label: Denali
arm group label: Option
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maureen P Kohi, M.D.
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
url: http://radiology.ucsf.edu
description: ucsf radiology home page
citation: Woodcock A, Campbell I, Collins JV, Hanson P, Harvey J, Corris P, Johnston ID. Bronchoscopy and infection control. Lancet. 1989 Jul 29;2(8657):270-1. doi: 10.1016/s0140-6736(89)90451-0. No abstract available.
PMID: 2569071
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The ODEN trial was initially powered to observe differences between the two filter types after 75 of each filter were to be placed. Due to the opening of the PRESERVE trial and slightly lower than expected enrollment, the trial was terminated early.
point of contact: 