<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/NCT02989376</url>
  </required_header>
  <id_info>
    <org_study_id>KohnanSN01</org_study_id>
    <nct_id>NCT02989376</nct_id>
  </id_info>
  <brief_title>Carotid Duplex Ultrasound for Selecting Patients for Endovascular Thrombectomy in Acute Stroke Patients</brief_title>
  <acronym>ECHO-SELECT</acronym>
  <official_title>Emergent Carotid Ultrasound in Hyperacute Cerebral Vessel Occlusion for Selecting Patients to be Treated With Endovascular Clot Retrieval Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ryo Itabashi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kohnan Hospital</source>
  <brief_summary>
    <textblock>
      The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular&#xD;
      imaging for selecting acute stroke patients for endovascular thrombectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>modified Rankin Scale</measure>
    <time_frame>at 90 days after onset</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Stroke, Acute</condition>
  <arm_group>
    <arm_group_label>carotid duplex ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm study. After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.</intervention_name>
    <description>When the ratio of the end diastolic velocity in the common carotid arteries is greater than 1.4 or the diastolic flow in the internal carotid artery is not detected by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. If vessel occlusion is not detected by carotid duplex ultrasound, additional vascular imaging including MR angiography or CT angiography is considered.</description>
    <arm_group_label>carotid duplex ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Endovascular treatment can be initiated within 6 hours of symptom onset.&#xD;
&#xD;
          -  ASPECTS of &gt;=6 is diagnosed by two or more stroke physicians.&#xD;
&#xD;
          -  The end diastolic velocity in the common carotid arteries or internal carotid artery&#xD;
             is evaluated by carotid duplex ultrasound&#xD;
&#xD;
          -  NIHSS score of &gt;=6.&#xD;
&#xD;
          -  Age&gt;=18 years.&#xD;
&#xD;
          -  Written informed consent is obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-stroke modified Rankin Scale (mRS) score &gt;=2.&#xD;
&#xD;
          -  Difficulties to evaluate ASPECTS on initial CT.&#xD;
&#xD;
          -  Difficulties to groin puncture.&#xD;
&#xD;
          -  History of severe allergic reaction to contrast medium.&#xD;
&#xD;
          -  End stage renal disease.&#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>Ryo Itabashi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kohnan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kohnan hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>9828523</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kohnan Hospital</investigator_affiliation>
    <investigator_full_name>Ryo Itabashi</investigator_full_name>
    <investigator_title>Department chair of Stroke Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989376
org study id: KohnanSN01
nct id: NCT02989376
lead sponsor: 
The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular
      imaging for selecting acute stroke patients for endovascular thrombectomy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: modified Rankin Scale
time frame: at 90 days after onset
arm group label: carotid duplex ultrasound
arm group type: Experimental
description: Single arm study. After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.
intervention type: Procedure
intervention name: After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.
description: When the ratio of the end diastolic velocity in the common carotid arteries is greater than 1.4 or the diastolic flow in the internal carotid artery is not detected by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. If vessel occlusion is not detected by carotid duplex ultrasound, additional vascular imaging including MR angiography or CT angiography is considered.
arm group label: carotid duplex ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ryo Itabashi, MD
role: Principal Investigator
affiliation: Kohnan Hospital
facility: 
country: Japan
responsible party type: Sponsor-Investigator
investigator affiliation: Kohnan Hospital
investigator full name: Ryo Itabashi
investigator title: Department chair of Stroke Neurology
mesh term: Stroke