<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/NCT04410146</url>
  </required_header>
  <id_info>
    <org_study_id>CIP-201912-SQUID</org_study_id>
    <nct_id>NCT04410146</nct_id>
  </id_info>
  <brief_title>The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)</brief_title>
  <acronym>STEM</acronym>
  <official_title>The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balt USA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Balt USA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1)&#xD;
      controlled trial designed to provide an assessment of the safety and effectiveness of Middle&#xD;
      Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural&#xD;
      Hematoma (cSDH)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study objective is to provide an assessment of the safety and effectiveness of Middle&#xD;
      Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural&#xD;
      Hematoma (cSDH).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>N/A</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>
    <masking_description>Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neurocognitive battery.&#xD;
Imaging assessment by blinded core laboratory</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Effectiveness Endpoint</measure>
    <time_frame>On 180-day from intervention</time_frame>
    <description>Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Effectiveness Endpoint</measure>
    <time_frame>Within 180-days of intervention</time_frame>
    <description>Treatment failure is defined by the occurrence of any of the following events:&#xD;
Re-operation (after index procedure) or surgical rescue&#xD;
Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint</measure>
    <time_frame>Within 30-days from intervention</time_frame>
    <description>Major disabling stroke or any death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mRS (analyzed as shift)</measure>
    <time_frame>180-day from intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any investigational device/procedure-related AE/SAE</measure>
    <time_frame>Through 1-year visit</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>mRS (analyzed as shift)</measure>
    <time_frame>30-day and 1-year from intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>mRS ≤ 2 (binary)</measure>
    <time_frame>30-day, 180-days, and 1-year from intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neuro-cognitive battery HVLT-R, COWAT, Animal Naming, Trail making tests</measure>
    <time_frame>Baseline, 30-day, 180-day, and 1-year from intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>EQ-5D-5L (including EQ-VAS)</measure>
    <time_frame>Baseline vs. 30-day, 180-day, and 1-year from intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospital Days</measure>
    <time_frame>Through 1-year visit</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intensive Care Unit (ICU) Days</measure>
    <time_frame>Through 1-year visit</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>NIHSS</measure>
    <time_frame>Baseline vs Discharge and 90-day</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>CT/MRI</measure>
    <time_frame>Baseline vs. 180 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">310</enrollment>
  <condition>Subdural Hematoma, Chronic</condition>
  <arm_group>
    <arm_group_label>SQUID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Embolization of the Middle Meningeal Artery (MMA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Embolization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Management</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SQUID Embolization</intervention_name>
    <description>Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent</description>
    <arm_group_label>SQUID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SQUID Embolization and Surgical Evacuation</intervention_name>
    <description>Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma</description>
    <arm_group_label>SQUID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Evacuation</intervention_name>
    <description>Surgical evacuation of the sub-dural hematoma</description>
    <arm_group_label>No Embolization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Other: Medical Management</intervention_name>
    <description>Standard</description>
    <arm_group_label>No Embolization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female Subject whose age is ≥ 30 at the time of consent&#xD;
&#xD;
          2. Pre-morbid mRS 0-1 within the previous 12 months&#xD;
&#xD;
          3. cSDH measures ≥ 10 mm in greatest thickness&#xD;
&#xD;
          4. cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical&#xD;
             flattening or midline shift&#xD;
&#xD;
          5. Imaging characteristics indicative of chronicity (≥ 50% of the volume of the&#xD;
             collection should be isodense or hypodense to normal cortical gray matter on Computed&#xD;
             Tomography (CT))&#xD;
&#xD;
          6. Subject presents with one or more of the following neurological symptoms: headache;&#xD;
             cognitive decline; speech difficulty or aphasia; gait impairment or imbalance; focal&#xD;
             neurological deficit (weakness, paresthesia or sensory deficit involving of one or&#xD;
             more extremities or facial droop); and/or seizure&#xD;
&#xD;
          7. Subject, or his/her legally authorized representative, understands the nature of the&#xD;
             procedure, consents to participation in the study and provides a signed Informed&#xD;
             Consent Form&#xD;
&#xD;
          8. Female Subjects of child-bearing potential must be able to provide a current negative&#xD;
             urine pregnancy test and agree to an appropriate method of contraception throughout&#xD;
             the trial&#xD;
&#xD;
          9. Subject is able and willing to return to the investigational site for all follow-up&#xD;
             visits (e.g., 30-day, 90-day, 180-day and 1-year), as required per protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject with prior ipsilateral craniotomy or burr hole evacuation of cSDH&#xD;
&#xD;
          2. Subject with prior Embolization of either MMA&#xD;
&#xD;
          3. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy&#xD;
&#xD;
          4. Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma&#xD;
             evacuation needed&#xD;
&#xD;
          5. Subject with a cSDH with a focal location (confined to the frontal or temporal base or&#xD;
             the inter-hemispheric space without cerebral convexity involvement)&#xD;
&#xD;
          6. cSDH developed due to underlying condition such as a vascular lesion, brain tumor,&#xD;
             arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous&#xD;
             craniotomy&#xD;
&#xD;
          7. Life expectancy of &lt;1 year&#xD;
&#xD;
          8. Subject who presents with an intracranial mass other than subdural hematoma&#xD;
&#xD;
          9. Subject who presents with a meningioma with mass effect and/or ≥1 cm or currently&#xD;
             undergoing radiation therapy for carcinoma or sarcoma of the head or neck region&#xD;
&#xD;
         10. Subject with serum creatinine level &gt; 3.0 mg/dL at time of enrollment (this will&#xD;
             restrict the use of contrast) and not on dialysis&#xD;
&#xD;
         11. Subject with significant liver function impairment at the time of enrollment&#xD;
&#xD;
         12. Subject with a life-threatening allergy to radiographic contrast (unless treatment for&#xD;
             allergy is tolerated or can be managed medically)&#xD;
&#xD;
         13. Subject who is currently enrolled in another investigational study protocol that could&#xD;
             potentially confound the current study endpoints&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Fiorella, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stony Brook University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adam Arthur, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmes-Murphy Neurologic and Spine Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barrow Neurological Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carondolet St. Joseph's</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Community Hospital</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Barbara Cottage Hospital</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Robles Hospital and Medical Center</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>92360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellstar Kennestone Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Health</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overlook Medical Center</name>
      <address>
        <city>Summit</city>
        <state>New Jersey</state>
        <zip>07901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Health Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist University Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cherry Hill</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Cote de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hopital Bicetre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hopital Maison Blanche</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nurnberg Sud</name>
      <address>
        <city>Nurnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gregorio Maranon Hospital</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningeal Arteries</keyword>
  <keyword>Intracranial Subdural Hematoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Chronic</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04410146
org study id: CIP-201912-SQUID
nct id: NCT04410146
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1)
      controlled trial designed to provide an assessment of the safety and effectiveness of Middle
      Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural
      Hematoma (cSDH)
The study objective is to provide an assessment of the safety and effectiveness of Middle
      Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural
      Hematoma (cSDH).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neurocognitive battery.
Imaging assessment by blinded core laboratory
measure: Primary Effectiveness Endpoint
time frame: On 180-day from intervention
description: Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.
measure: Primary Effectiveness Endpoint
time frame: Within 180-days of intervention
description: Treatment failure is defined by the occurrence of any of the following events:
Re-operation (after index procedure) or surgical rescue
Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause
measure: Primary Safety Endpoint
time frame: Within 30-days from intervention
description: Major disabling stroke or any death
measure: mRS (analyzed as shift)
time frame: 180-day from intervention
measure: Any investigational device/procedure-related AE/SAE
time frame: Through 1-year visit
measure: mRS (analyzed as shift)
time frame: 30-day and 1-year from intervention
measure: mRS ≤ 2 (binary)
time frame: 30-day, 180-days, and 1-year from intervention
measure: Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neuro-cognitive battery HVLT-R, COWAT, Animal Naming, Trail making tests
time frame: Baseline, 30-day, 180-day, and 1-year from intervention
measure: EQ-5D-5L (including EQ-VAS)
time frame: Baseline vs. 30-day, 180-day, and 1-year from intervention
measure: Hospital Days
time frame: Through 1-year visit
measure: Intensive Care Unit (ICU) Days
time frame: Through 1-year visit
measure: NIHSS
time frame: Baseline vs Discharge and 90-day
measure: CT/MRI
time frame: Baseline vs. 180 days
arm group label: SQUID
arm group type: Experimental
description: Embolization of the Middle Meningeal Artery (MMA)
arm group label: No Embolization
arm group type: Active Comparator
description: Standard Management
intervention type: Device
intervention name: SQUID Embolization
description: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent
arm group label: SQUID
intervention type: Device
intervention name: SQUID Embolization and Surgical Evacuation
description: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma
arm group label: SQUID
intervention type: Procedure
intervention name: Surgical Evacuation
description: Surgical evacuation of the sub-dural hematoma
arm group label: No Embolization
intervention type: Other
intervention name: Other: Medical Management
description: Standard
arm group label: No Embolization
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: David Fiorella, MD, PhD
role: Principal Investigator
affiliation: Stony Brook University Medical Center
last name: Adam Arthur, MD, MPH
role: Principal Investigator
affiliation: Semmes-Murphy Neurologic and Spine Institute
facility: 
facility: 
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facility: 
facility: 
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country: France
country: Germany
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Chronic
mesh term: Hematoma
sharing ipd: No