<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/NCT01685567</url>
  </required_header>
  <id_info>
    <org_study_id>SRM-2012-02</org_study_id>
    <nct_id>NCT01685567</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure</brief_title>
  <acronym>ROADSTER</acronym>
  <official_title>INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silk Road Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Silk Road Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™&#xD;
      Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection&#xD;
      during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also&#xD;
      facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or&#xD;
      diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA&#xD;
      approved carotid artery stent for the treatment of carotid artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe&#xD;
      adverse neurological effects. Most major clinical studies of CAS have used distal filters for&#xD;
      cerebral protection and have compared the neurologic complication rates with those of carotid&#xD;
      endarterectomy (CEA). Many currently available embolic protection devices, however, have&#xD;
      limited efficacy in capturing microembolic debris that is liberated during stenting,&#xD;
      pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the&#xD;
      need to cross the lesion prior to deployment. Some studies have shown a relatively high&#xD;
      incidence of cerebral infarction even when distal protection devices are employed.&#xD;
&#xD;
      Cerebral protection with carotid flow reversal is a method that was developed as an&#xD;
      alternative to the use of distal protection devices. While novel in its approach, this method&#xD;
      too has its limitations. Another technique developed employs carotid flow reversal prior to&#xD;
      traversing the stenosis and can be accomplished by directly accessing the carotid anatomy&#xD;
      without the use of the transfemoral approach. Major benefits to this method include a simpler&#xD;
      route to the target lesion and the ability to perform the procedure on patients with severe&#xD;
      carotid tortuosity and difficult aortic arch anatomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hierarchical Composite of Stroke, Myocardial Infarction, and Death</measure>
    <time_frame>30-day post-procedure</time_frame>
    <description>The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All Death (Non-hierarchical)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Myocardial Infarctions (Non-hierarchical)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Stroke (Non-hierarchical)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ipsilateral Stroke (Non-hierarchical)</measure>
    <time_frame>31-365 days</time_frame>
    <description>Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Carotid Artery Disease</condition>
  <arm_group>
    <arm_group_label>MICHI NPS+f</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The MICHI™ NPS+f is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify to the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MICHI NPS+f</intervention_name>
    <description>Cerebral protection with carotid flow reversal</description>
    <arm_group_label>MICHI NPS+f</arm_group_label>
    <other_name>ENROUTE Transcarotid Neuroprotection System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient must meet one of the following criteria regarding neurological symptom status&#xD;
             and degree of stenosis:&#xD;
&#xD;
               -  Symptomatic: Stenosis must be greater than or equal to 50% as determined by&#xD;
                  angiogram and the patient has a history of stroke (minor or non-disabling), TIA&#xD;
                  and/or amaurosis fugax within 180 days of the procedure.&#xD;
&#xD;
               -  Asymptomatic: Stenosis must be greater than or equal to 70% as determined by&#xD;
                  angiogram without any neurological symptoms within the prior 180 days.&#xD;
&#xD;
          2. Target vessel must meet diameter requirements for stent (refer to selected stent IFU&#xD;
             for diameter requirements).&#xD;
&#xD;
          3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or&#xD;
             without involvement of the contiguous common carotid artery (CCA).&#xD;
&#xD;
          4. Patient is greater or equal to 18 years of age.&#xD;
&#xD;
          5. Patient has no childbearing potential or has a negative pregnancy test within one week&#xD;
             prior to the study procedure.&#xD;
&#xD;
          6. Patient understands the nature of the procedure and has provided a signed informed&#xD;
             consent using a form that has been reviewed and approved by the Investigational Review&#xD;
             Board/Ethics Committee of the respective clinical site prior to the procedure. This&#xD;
             will be obtained prior to participation in the study.&#xD;
&#xD;
          7. Patient is willing to comply with the protocol requirements and return to the&#xD;
             treatment center for all required clinical evaluations.&#xD;
&#xD;
          8. Patient meets at least one of the anatomic or clinical high-risk criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has chronic atrial fibrillation.&#xD;
&#xD;
          2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6&#xD;
             months, or history of paroxysmal atrial fibrillation requiring chronic&#xD;
             anticoagulation.&#xD;
&#xD;
          3. Patient has an evolving stroke.&#xD;
&#xD;
          4. Patient has severe dementia.&#xD;
&#xD;
          5. Patient has a history of spontaneous intracranial hemorrhage within the past 12&#xD;
             months.&#xD;
&#xD;
          6. Patient has had a recent (&lt;7 days) stroke of sufficient size (on CT or MRI) to place&#xD;
             him or her at risk of hemorrhagic conversion during the procedure.&#xD;
&#xD;
          7. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.&#xD;
&#xD;
          8. Patient has active bleeding diathesis or coagulopathy or will refuse blood&#xD;
             transfusion.&#xD;
&#xD;
          9. Patient had or will have CABG, endovascular stent procedure, valve intervention or&#xD;
             vascular surgery within 30 days before or after the intervention.&#xD;
&#xD;
         10. Patient has had a recent GI bleed that would interfere with antiplatelet therapy.&#xD;
&#xD;
         11. Life expectancy of &lt; 12 months post procedure.&#xD;
&#xD;
         12. Patient has history of intolerance or allergic reaction to any of the study&#xD;
             medications or stent materials (refer to stent IFU), including aspirin (ASA),&#xD;
             ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre&#xD;
             medicated). Patients must be able to tolerate statins and a combination of ASA and&#xD;
             ticlopidine, ASA and clopidogrel or ASA and prasugrel.&#xD;
&#xD;
         13. Myocardial Infarction within 72 hours prior to the intervention.&#xD;
&#xD;
         14. Presence of a previous placed intravascular stent in target vessel or the planned&#xD;
             arteriotomy site.&#xD;
&#xD;
         15. Patient has had neurologic illnesses within the past two years characterized by&#xD;
             fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke&#xD;
             (e.g. partial or secondarily generalized seizures, complicated or classic migraine,&#xD;
             tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or&#xD;
             other post-traumatic lesions, intracranial infection, demyelinating disease, moderate&#xD;
             to severe dementia, or intracranial hemorrhage).&#xD;
&#xD;
         16. Patient with a history of major stroke (CVA or retinal embolus) with major&#xD;
             neurological deficit likely to confound study endpoints within 1 month of index&#xD;
             procedure.&#xD;
&#xD;
         17. Patient has Hgb &lt;10 g/dl, platelet count &lt;125,000/μl, uncorrected INR &gt;1.5, bleeding&#xD;
             time &gt;1 minute beyond upper limit normal, or heparin-associated thrombocytopenia.&#xD;
&#xD;
         18. Patient has an intracranial tumor.&#xD;
&#xD;
         19. Patient is actively participating in another drug or device trial (IND or IDE) that&#xD;
             has not completed the required protocol follow-up period.&#xD;
&#xD;
         20. Patient has inability to understand and cooperate with study procedures or provide&#xD;
             informed consent.&#xD;
&#xD;
         21. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] &quot;string sign&quot; &gt;1cm&#xD;
             of the ipsilateral common or internal carotid artery.&#xD;
&#xD;
         22. Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable&#xD;
             symptoms referable to the study carotid artery.&#xD;
&#xD;
         23. Knowledge of cardiac sources of emboli.e.g. left ventricular aneurysm, intracardiac&#xD;
             filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific&#xD;
             aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal&#xD;
             aneurysm, or left atrial myxoma).&#xD;
&#xD;
         24. Recently (&lt;60 days) implanted heart valve (either surgically or endovascularly), which&#xD;
             is a known source of emboli as confirmed on echocardiogram.&#xD;
&#xD;
         25. Ostium of Common Carotid Artery (CCA) requires revascularization.&#xD;
&#xD;
         26. Presence of extensive or diffuse atherosclerotic disease involving the proximal common&#xD;
             carotid artery that would preclude the safe introduction of the study device.&#xD;
&#xD;
         27. The patient has less than 5cm between the clavicle and bifurcation, as assessed by&#xD;
             duplex Doppler ultrasound.&#xD;
&#xD;
         28. Bilateral carotid stenosis if intervention is planned within 37 days of the index&#xD;
             procedure.&#xD;
&#xD;
         29. An intraluminal filling defect (defined as an endoluminal lucency surrounded by&#xD;
             contrast, seen in multiple angiographic projections, in the absence of angiographic&#xD;
             evidence of calcification) that is not associated with an ulcerated target lesion.&#xD;
&#xD;
         30. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial&#xD;
             stenosis greater in severity than the lesion to be treated, cerebral aneurysm &gt; 5 mm,&#xD;
             AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal&#xD;
             angiographic findings.&#xD;
&#xD;
         31. Patient has had a previous intervention in the ipsilateral proximal CCA.&#xD;
&#xD;
         32. Patient has had a TIA or amaurosis fugax within 48 hours prior to the procedure.&#xD;
&#xD;
         33. Patient has contralateral lateral recurrent, laryngeal or vagus nerve injury.&#xD;
&#xD;
         34. Patient is otherwise unsuitable for intervention in the opinion of the investigator.&#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>Christopher Kwolek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard Cambria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peter Morton UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Medical Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5967</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Regional Medical Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University at Buffalo Neurosurgery, Inc</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center and Case Western Reserve University School of Medicine</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jobst Vascular Institute</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Heart</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Hospital System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiothoracic &amp; Vascular Surgeons</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas VA Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Vascular Specialists</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Salud</name>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=26506270</url>
    <description>Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/28335706</url>
    <description>Transcarotid Artery Revascularization with Flow Reversal: the PROOF Study</description>
  </link>
  <results_reference>
    <citation>Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460.</citation>
    <PMID>26506270</PMID>
  </results_reference>
  <results_reference>
    <citation>Alpaslan A, Wintermark M, Pinter L, Macdonald S, Ruedy R, Kolvenbach R. Transcarotid Artery Revascularization With Flow Reversal. J Endovasc Ther. 2017 Apr;24(2):265-270. doi: 10.1177/1526602817693607. Epub 2017 Feb 17.</citation>
    <PMID>28335706</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>December 20, 2016</results_first_submitted>
  <results_first_submitted_qc>January 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2017</results_first_posted>
  <last_update_submitted>June 12, 2017</last_update_submitted>
  <last_update_submitted_qc>June 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>carotid artery disease</keyword>
  <keyword>reverse flow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment opened November, 2012 and ended March, 2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Intention-to-Treat (ITT)</title>
          <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="219"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="219"/>
              </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>Intention-to-Treat (ITT)</title>
          <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="219"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.30" spread="8.574"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Symptomatic Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asymptomatic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Symptomatic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hierarchical Composite of Stroke, Myocardial Infarction, and Death</title>
        <description>The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.</description>
        <time_frame>30-day post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intention-to-Treat (ITT)</title>
            <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Hierarchical Composite of Stroke, Myocardial Infarction, and Death</title>
          <description>The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.</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="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Death (Non-hierarchical)</title>
        <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</description>
        <time_frame>0 to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intention-to-Treat (ITT)</title>
            <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>All Death (Non-hierarchical)</title>
          <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</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="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Myocardial Infarctions (Non-hierarchical)</title>
        <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</description>
        <time_frame>0 to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intention-to-Treat (ITT)</title>
            <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>All Myocardial Infarctions (Non-hierarchical)</title>
          <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</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="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Stroke (Non-hierarchical)</title>
        <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</description>
        <time_frame>0 to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intention-to-Treat (ITT)</title>
            <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>All Stroke (Non-hierarchical)</title>
          <description>The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.</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="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ipsilateral Stroke (Non-hierarchical)</title>
        <description>Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.</description>
        <time_frame>31-365 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intention-to-Treat (ITT)</title>
            <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Ipsilateral Stroke (Non-hierarchical)</title>
          <description>Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.</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="219"/>
              </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>
      <group_list>
        <group group_id="E1">
          <title>Intention-to-Treat (ITT)</title>
          <description>All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Post Procedural Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Incision Site Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Troponin Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Psychomotor Seizures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Artery Dissection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </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="118" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Ventricular Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Device Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Vessel Puncture Site Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy To Arthropod Bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Adenoviral Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Post Procedural Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Rash Pustular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Cranial Nerve Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Incision Site Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Vascular Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Wound Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Wound Secretion</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatine Phosphokinase Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Oxygen Saturation Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Troponin Increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypokalaemic Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Psychomotor Seizures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hallucination, Visual</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Skin Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Therapy Regimen Changed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Artery Dissection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Vascular Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
              </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>Linda Ruedy. Sr. Director, Clinical and Regulatory Affairs</name_or_title>
      <organization>Silk Road Medical, Inc.</organization>
      <phone>(408) 585-2113</phone>
      <email>lruedy@silkroadmed.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/NCT01685567
org study id: SRM-2012-02
nct id: NCT01685567
lead sponsor: 
has dmc: Yes
The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™
      Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection
      during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also
      facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or
      diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA
      approved carotid artery stent for the treatment of carotid artery disease.
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe
      adverse neurological effects. Most major clinical studies of CAS have used distal filters for
      cerebral protection and have compared the neurologic complication rates with those of carotid
      endarterectomy (CEA). Many currently available embolic protection devices, however, have
      limited efficacy in capturing microembolic debris that is liberated during stenting,
      pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the
      need to cross the lesion prior to deployment. Some studies have shown a relatively high
      incidence of cerebral infarction even when distal protection devices are employed.

      Cerebral protection with carotid flow reversal is a method that was developed as an
      alternative to the use of distal protection devices. While novel in its approach, this method
      too has its limitations. Another technique developed employs carotid flow reversal prior to
      traversing the stenosis and can be accomplished by directly accessing the carotid anatomy
      without the use of the transfemoral approach. Major benefits to this method include a simpler
      route to the target lesion and the ability to perform the procedure on patients with severe
      carotid tortuosity and difficult aortic arch anatomy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Hierarchical Composite of Stroke, Myocardial Infarction, and Death
time frame: 30-day post-procedure
description: The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.
measure: All Death (Non-hierarchical)
time frame: 0 to 30 days
description: The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
measure: All Myocardial Infarctions (Non-hierarchical)
time frame: 0 to 30 days
description: The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
measure: All Stroke (Non-hierarchical)
time frame: 0 to 30 days
description: The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
measure: Ipsilateral Stroke (Non-hierarchical)
time frame: 31-365 days
description: Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.
arm group label: MICHI NPS+f
arm group type: Experimental
description: The MICHI™ NPS+f is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify to the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.
intervention type: Device
intervention name: MICHI NPS+f
description: Cerebral protection with carotid flow reversal
arm group label: MICHI NPS+f
other name: ENROUTE Transcarotid Neuroprotection System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher Kwolek, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Richard Cambria, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
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country: Spain
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=26506270
description: Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.
url: https://www.ncbi.nlm.nih.gov/pubmed/28335706
description: Transcarotid Artery Revascularization with Flow Reversal: the PROOF Study
citation: Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460.
PMID: 26506270
citation: Alpaslan A, Wintermark M, Pinter L, Macdonald S, Ruedy R, Kolvenbach R. Transcarotid Artery Revascularization With Flow Reversal. J Endovasc Ther. 2017 Apr;24(2):265-270. doi: 10.1177/1526602817693607. Epub 2017 Feb 17.
PMID: 28335706
responsible party type: Sponsor
mesh term: Carotid Artery Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 