<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/NCT03036631</url>
  </required_header>
  <id_info>
    <org_study_id>20150455</org_study_id>
    <nct_id>NCT03036631</nct_id>
  </id_info>
  <brief_title>Ideal Sedation for Stroke Thrombectomy</brief_title>
  <acronym>ISST</acronym>
  <official_title>Ideal Sedation for Stroke Thrombectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. M. Asif Taqi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurovascular Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions&#xD;
      whether sedation with intubation and paralytics is feasible and whether it delays the time to&#xD;
      recanalization in comparison with conscious sedation alone. As a pilot registry, it is&#xD;
      anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18&#xD;
      months. Following enrollment, data will be collected prospectively from medical records and&#xD;
      from patients' visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Time interval between groin puncture and final recanalization</measure>
    <time_frame>6 months or at study completion</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Conscious Sedation/Monitored Anesthesia Care</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>General Anesthesia</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients underwent mechanical thrombectomy at Los Robles hospital, Thousand Oaks, CA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Suitable for intra-arterial treatment for acute stroke up to 8 hours from onset of&#xD;
             symptoms&#xD;
&#xD;
          -  Clinical equipoise for best mode of sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known allergy to either proposed medication and its alternative&#xD;
&#xD;
          -  Any patient that has been intubated prior to randomization&#xD;
&#xD;
          -  Posterior circulation strokes&#xD;
&#xD;
          -  Age ≤ 18&#xD;
&#xD;
          -  Pregnant female&#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>Muhammad A Taqi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neurovascular Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Los Robles Hospital and Medical Center</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>July 17, 2018</last_update_submitted>
  <last_update_submitted_qc>July 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Neurovascular Research Foundation</investigator_affiliation>
    <investigator_full_name>Dr. M. Asif Taqi</investigator_full_name>
    <investigator_title>Director Neuroendovascular</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic 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/NCT03036631
org study id: 20150455
nct id: NCT03036631
lead sponsor: 
has dmc: No
The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions
      whether sedation with intubation and paralytics is feasible and whether it delays the time to
      recanalization in comparison with conscious sedation alone. As a pilot registry, it is
      anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18
      months. Following enrollment, data will be collected prospectively from medical records and
      from patients' visits.
observational model: Case-Control
time perspective: Prospective
measure: Time interval between groin puncture and final recanalization
time frame: 6 months or at study completion
arm group label: Conscious Sedation/Monitored Anesthesia Care
arm group label: General Anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Muhammad A Taqi
role: Principal Investigator
affiliation: Neurovascular Research Foundation
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Neurovascular Research Foundation
investigator full name: Dr. M. Asif Taqi
investigator title: Director Neuroendovascular
mesh term: Stroke
mesh term: Ischemic Stroke