<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/NCT03263117</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-17-0436</org_study_id>
    <nct_id>NCT03263117</nct_id>
  </id_info>
  <brief_title>SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke</brief_title>
  <acronym>SEGA</acronym>
  <official_title>SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker Neurovascular</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives:&#xD;
&#xD;
      This study aims to estimate overall treatment benefit (improvement in disability) among acute&#xD;
      ischemic stroke patients that are randomized to General Anesthesia (GA) compared with&#xD;
      Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of&#xD;
      symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural&#xD;
      complications, reperfusion; and quality of life.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to&#xD;
      sedation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">April 22, 2023</completion_date>
  <primary_completion_date type="Actual">April 22, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>modified Rankin Scale (mRS)</measure>
    <time_frame>90 days</time_frame>
    <description>Comparison of independent clinical outcome as measured by the modified Rankin Scale (mRS) at 90 days (scores 5 and 6 combined) among patients randomized to GA versus Sedation assessed by study personnel blinded to treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dichotomized modified Rankin Scale (mRS)</measure>
    <time_frame>90 days</time_frame>
    <description>Dichotomized modified Rankin Scale (mRS) at 90 days (0-2 vs 3-6) adjusted for stratification variable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of recanalization</measure>
    <time_frame>post procedure within 6 hours</time_frame>
    <description>Rates of recanalization using modified TICI scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health Stroke Scale (NIHSS) scale</measure>
    <time_frame>24-36 hours post procedure</time_frame>
    <description>Early clinical improvement measured by difference NIHSS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Scale (mRS)</measure>
    <time_frame>90 days</time_frame>
    <description>Independent functional outcome in General Anesthesia patients treated with inhalational vs. intravenous medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the European Quality of Life-5 Dimensions (EQ-5D) instrument</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of symptomatic intracerebral hemorrhage</measure>
    <time_frame>18-36 hours post procedure</time_frame>
    <description>Safety measured by incidence of symptomatic intracerebral hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mortality</measure>
    <time_frame>18-36 hours post procedure</time_frame>
    <description>Safety measured by incidence of mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of device related complications</measure>
    <time_frame>18-36 hours post procedure</time_frame>
    <description>Safety measured by incidence of device related complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Sedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General Anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sedation</intervention_name>
    <description>The protocol does not specify a particular combination of drugs that must be used for sedation.&#xD;
The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.</description>
    <arm_group_label>Sedation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>General Anesthesia (GA)</intervention_name>
    <description>The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.&#xD;
The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)</description>
    <arm_group_label>General Anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intra-arterial Thrombectomy</intervention_name>
    <description>The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.</description>
    <arm_group_label>General Anesthesia</arm_group_label>
    <arm_group_label>Sedation</arm_group_label>
    <other_name>Endovascular Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on&#xD;
             CT-angiography in the following anterior circulation locations that will be treated by&#xD;
             endovascular therapy (EVT):&#xD;
&#xD;
               1. Internal Carotid Artery (terminal &quot;T&quot; or &quot;L-type&quot;- occlusion)&#xD;
&#xD;
               2. Middle Cerebral Artery (MCA) M1 or proximal M2&#xD;
&#xD;
               3. Anterior Cerebral Artery (ACA) A1 or proximal A2&#xD;
&#xD;
                    -  Patients who receive IV-tPA thrombolysis are eligible provided the drug was&#xD;
                       delivered within 4.5 hours of stroke onset or last seen normal and in&#xD;
                       accordance with local hospital standard of care.&#xD;
&#xD;
          2. Ages 18-90.&#xD;
&#xD;
          3. National Institute of Health Stroke Scale (NIHSS) score 6-30&#xD;
&#xD;
          4. Time of from stroke symptom onset of last seen normal to start of EVT (defined as&#xD;
             groin puncture) ≤ 16 hours.&#xD;
&#xD;
          5. Limited infarct core, as defined below and adapted from the 2018 American Heart&#xD;
             Association guidelines&#xD;
&#xD;
               1. For patients presenting ≤ 6 hours from time of symptom onset or last seen normal,&#xD;
                  Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6&#xD;
&#xD;
               2. For patients presenting &gt; 6 hours and ≤ 16 hours from time of symptom onset or&#xD;
                  last seen normal, they must satisfy EITHER ONE of the two following criteria:&#xD;
&#xD;
             i. Ischemic core by CT Perfusion or MRI/MR Perfusion &lt; 70 mL, a ratio of volume of&#xD;
             penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue&#xD;
             of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of &lt; 31 mL by CT&#xD;
             Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core &lt; 51 mL.&#xD;
&#xD;
          6. Subject willing/able to return for protocol required follow up visits.&#xD;
&#xD;
          7. No significant pre-stroke disability (modified Rankin Score must be ≤ 2).&#xD;
&#xD;
          8. Females of childbearing potential must have a negative serum or urine pregnancy test.&#xD;
&#xD;
          9. Patient or patient's legally authorized representative has given Informed Consent&#xD;
             according to Good Clinical Practices (GCP) and/or local IRB policies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Coma on admission (Glasgow Coma Scale &lt;8), need for intubation upon ED arrival, or&#xD;
             transferred patients who present previously intubated.&#xD;
&#xD;
          2. Severe agitation or seizures on admission that preclude safe vascular access.&#xD;
&#xD;
          3. Loss of airway protective reflexes and/or vomiting on admission.&#xD;
&#xD;
          4. Predicted or known difficult airway.&#xD;
&#xD;
          5. Pre-existing neurological or psychiatric disease that would confound the neurological&#xD;
             or functional evaluations, e.g. dementia.&#xD;
&#xD;
          6. Presumed septic embolus, or suspicion of bacterial endocarditis&#xD;
&#xD;
          7. Currently participating or has participated in any investigational drug or device&#xD;
             study within 30 days.&#xD;
&#xD;
          8. Inability to follow-up for 90-day assessment.&#xD;
&#xD;
          9. Known history of allergy to anesthesia drugs.&#xD;
&#xD;
         10. Known history or family history of malignant hyperthermia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peng Roc Chen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrew Barreto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos Artime, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sunil Sheth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sean Savitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claudia Pedroza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University College of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>48150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Regional Health</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Health</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Hospital System - Memorial City Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Hospital System - The Woodlands Medical Center</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Peng Roc Chen, MD</investigator_full_name>
    <investigator_title>Professor in Neurosurgery</investigator_title>
  </responsible_party>
  <keyword>Acute stroke</keyword>
  <keyword>Cerebral Stroke</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03263117
org study id: HSC-MS-17-0436
nct id: NCT03263117
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Objectives:

      This study aims to estimate overall treatment benefit (improvement in disability) among acute
      ischemic stroke patients that are randomized to General Anesthesia (GA) compared with
      Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of
      symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural
      complications, reperfusion; and quality of life.

      Hypothesis:

      GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to
      sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: modified Rankin Scale (mRS)
time frame: 90 days
description: Comparison of independent clinical outcome as measured by the modified Rankin Scale (mRS) at 90 days (scores 5 and 6 combined) among patients randomized to GA versus Sedation assessed by study personnel blinded to treatment.
measure: Dichotomized modified Rankin Scale (mRS)
time frame: 90 days
description: Dichotomized modified Rankin Scale (mRS) at 90 days (0-2 vs 3-6) adjusted for stratification variable
measure: Rates of recanalization
time frame: post procedure within 6 hours
description: Rates of recanalization using modified TICI scores
measure: National Institute of Health Stroke Scale (NIHSS) scale
time frame: 24-36 hours post procedure
description: Early clinical improvement measured by difference NIHSS scale
measure: modified Rankin Scale (mRS)
time frame: 90 days
description: Independent functional outcome in General Anesthesia patients treated with inhalational vs. intravenous medications.
measure: Quality of life as assessed by the European Quality of Life-5 Dimensions (EQ-5D) instrument
time frame: 90 days
measure: Incidence of symptomatic intracerebral hemorrhage
time frame: 18-36 hours post procedure
description: Safety measured by incidence of symptomatic intracerebral hemorrhage
measure: Incidence of mortality
time frame: 18-36 hours post procedure
description: Safety measured by incidence of mortality
measure: Incidence of device related complications
time frame: 18-36 hours post procedure
description: Safety measured by incidence of device related complications
arm group label: Sedation
arm group type: Active Comparator
description: The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist.
arm group label: General Anesthesia
arm group type: Active Comparator
description: The protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist.
intervention type: Drug
intervention name: Sedation
description: The protocol does not specify a particular combination of drugs that must be used for sedation.
The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
arm group label: Sedation
intervention type: Drug
intervention name: General Anesthesia (GA)
description: The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)
arm group label: General Anesthesia
intervention type: Procedure
intervention name: Intra-arterial Thrombectomy
description: The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.
arm group label: General Anesthesia
arm group label: Sedation
other name: Endovascular Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Peng Roc Chen, MD
role: Study Chair
affiliation: The University of Texas Health Science Center, Houston
last name: Andrew Barreto, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Carlos Artime, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Sunil Sheth, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Sean Savitz, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Claudia Pedroza, PhD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Peng Roc Chen, MD
investigator title: Professor in Neurosurgery
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Anesthetics