<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/NCT03816202</url>
  </required_header>
  <id_info>
    <org_study_id>C-SCS-001</org_study_id>
    <nct_id>NCT03816202</nct_id>
  </id_info>
  <brief_title>Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)</brief_title>
  <official_title>Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Integra LifeSciences Corporation</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>
      The primary objective of this study is to retrospectively investigate the safety and efficacy&#xD;
      of the Integra Sundt™ carotid shunt during endarterectomy procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2019</start_date>
  <completion_date type="Actual">August 27, 2019</completion_date>
  <primary_completion_date type="Actual">August 27, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal</measure>
    <time_frame>up to 60 days post-procedure</time_frame>
    <description>Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Carotid Artery Stenosis</condition>
  <arm_group>
    <arm_group_label>Sundt Carotid Shunt</arm_group_label>
    <description>Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sundt carotid shunt</intervention_name>
    <description>The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.</description>
    <arm_group_label>Sundt Carotid Shunt</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects participating in the study have undergone a carotid endarterectomy procedure with&#xD;
        the use of the Sundt™ carotid shunt prior to study initiation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18-80 years old&#xD;
&#xD;
          -  Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or&#xD;
             before date of study initiation&#xD;
&#xD;
          -  Availability of records on post-operative imaging of the carotid artery either by&#xD;
             carotid duplex ultrasound or angiogram&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insertion of a carotid shunt at the site of an infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Tummon</last_name>
    <role>Study Director</role>
    <affiliation>Integra LifeSciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Institute of Deaconess Clinic</name>
      <address>
        <city>Newburgh</city>
        <state>Indiana</state>
        <zip>47630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack Meridian Health</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <results_first_submitted>June 29, 2021</results_first_submitted>
  <results_first_submitted_qc>January 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 14, 2022</results_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</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>November 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03816202/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03816202/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sundt Carotid Shunt</title>
          <description>Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sundt Carotid Shunt</title>
          <description>Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.5" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal</title>
        <description>Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal</description>
        <time_frame>up to 60 days post-procedure</time_frame>
        <population>number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal</population>
        <group_list>
          <group group_id="O1">
            <title>Sundt Carotid Shunt</title>
            <description>Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt</description>
          </group>
        </group_list>
        <measure>
          <title>Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal</title>
          <description>Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal</description>
          <population>number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal</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="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Retrospective chart review of AEs that occurred between Surgery (Day 0) and 60 days post-operatively.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sundt Carotid Shunt</title>
          <description>number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Artery injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral Ischemia Injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
              </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>
    <point_of_contact>
      <name_or_title>Andrew Tummon, Director, Global Clinical Trials</name_or_title>
      <organization>Integra LifeSciences</organization>
      <phone>609-936-5490</phone>
      <email>andrew.tummon@integralife.com</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/NCT03816202
org study id: C-SCS-001
nct id: NCT03816202
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary objective of this study is to retrospectively investigate the safety and efficacy
      of the Integra Sundt™ carotid shunt during endarterectomy procedures.
observational model: Other
time perspective: Retrospective
measure: Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
time frame: up to 60 days post-procedure
description: Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
arm group label: Sundt Carotid Shunt
description: Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
intervention type: Device
intervention name: Sundt carotid shunt
description: The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.
arm group label: Sundt Carotid Shunt
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Andrew Tummon
role: Study Director
affiliation: Integra LifeSciences
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carotid Stenosis
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 