<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/NCT03307395</url>
  </required_header>
  <id_info>
    <org_study_id>1611017746</org_study_id>
    <nct_id>NCT03307395</nct_id>
  </id_info>
  <brief_title>Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma</brief_title>
  <official_title>Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has&#xD;
      been attempted with the goal of eliminating the arterial supply to the vascularized membrane.&#xD;
      The investigators have recently presented the first known case series of MMA embolization as&#xD;
      upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five&#xD;
      patients underwent successful embolization of the MMA with subsequent reduction in size or&#xD;
      complete resolution of cSDH with no peri-procedural complications.&#xD;
&#xD;
      The purpose of this study will be to evaluate the safety and efficacy of MMA embolization&#xD;
      compared to traditional surgical management for symptomatic, chronic, and medically&#xD;
      refractory SDH. MMA embolization is an established procedure used routinely for treatment of&#xD;
      tumors or vascular malformations; this study investigates the use of an established procedure&#xD;
      for a new disease. The investigators hypothesize that MMA embolization will afford a&#xD;
      particularly fragile patient population an alternative to invasive and morbid neurosurgical&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study will be to evaluate the safety and efficacy of middle meningeal&#xD;
      artery (MMA) embolization compared to traditional surgical management for symptomatic,&#xD;
      chronic, and medically refractory subdural hematoma (SDH). MMA embolization is an established&#xD;
      procedure used routinely for treatment of tumors or vascular malformations; this study&#xD;
      investigates the use of an established procedure for a new disease. The investigators&#xD;
      hypothesize that MMA embolization will afford a particularly fragile patient population an&#xD;
      alternative to invasive and morbid neurosurgical intervention.&#xD;
&#xD;
      Since subjects being enrolled will be those that are symptomatic from chronic SDH,&#xD;
      pre-procedural data such as clinical history, neurologic examination, and CT scans will&#xD;
      already be available. The day after the embolization, subjects will undergo a clinical&#xD;
      interview to assess change in symptoms. A neurologic exam and CT scan will also be performed&#xD;
      prior to discharge. Telephone surveys will be used at intermittent time points to assess for&#xD;
      change in clinical symptoms. The subjects will also present in clinic for a follow up&#xD;
      clinical interview, neurologic exam, and CT scan at 2 and 6 weeks post-procedure. This follow&#xD;
      up care including the CT scans is considered standard of care for patients undergoing surgery&#xD;
      for chronic SDH and it will not expose them to any additional tests or imaging studies.&#xD;
&#xD;
      MMA embolization is done under moderate sedation or general anesthesia using biplane&#xD;
      fluoroscopy. Briefly, common femoral artery access is obtained, and a guide catheter is&#xD;
      advanced into the external carotid artery. A microcatheter is then advanced into the internal&#xD;
      maxillary artery and then the MMA. Particles are then injected. A post-procedure carotid&#xD;
      angiography is performed to ensure no reflux of particles into the internal carotid artery&#xD;
      circulation. The guide catheter is then removed and femoral hemostasis is obtained. Subjects&#xD;
      recover from anesthesia and are observed overnight, undergo a non-contrast head CT the next&#xD;
      day, and discharged if appropriate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</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>Changes in neurological status after embolization of the MMA for symptomatic, chronic, and medically refractory SDH.</measure>
    <time_frame>The neurological exam will be performed before the procedure, the day after the procedure, and at 2 and 6 weeks post-procedure to assess any changes in neurological status.</time_frame>
    <description>A neurological exam will be performed to assess any neurological changes post-procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in size of the SDH post-procedure.</measure>
    <time_frame>A head CT will be performed to assess the size of the SDH post-procedure. This will occur before the procedure, the day after the procedure, and at 2 and 6 weeks post-procedure.</time_frame>
    <description>A CT scan will be performed to assess the size of the SDH before and after the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The safety of embolization of the MMA for symptomatic, chronic, and medically refractory SDH</measure>
    <time_frame>Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure.</time_frame>
    <description>A neurologic exam will be performed to assess any neurological deficits and/or improvements post-procedure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Chronic Subdural Hematoma</condition>
  <arm_group>
    <arm_group_label>Middle Meningeal Artery Embolization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Middel Meningeal Artery Embolization</intervention_name>
    <description>Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.</description>
    <arm_group_label>Middle Meningeal Artery Embolization</arm_group_label>
    <other_name>MMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age must be greater or equal to 18 years of age.&#xD;
&#xD;
          -  Subjects must have a diagnosis of chronic or acute-on-chronic subdural hematoma based&#xD;
             on brain imaging, as documented by an independent radiologist.&#xD;
&#xD;
          -  One or more symptoms attributable to chronic SDH including headache, cognitive&#xD;
             impairment, gait instability, seizure, or mild focal neurologic deficit.&#xD;
&#xD;
          -  In the opinion of the site investigator or the subject's referring physician, the&#xD;
             subject has failed conservative management.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subdural hematoma is causing mass effect significant enough to cause marked or&#xD;
             progressive neurologic impairment.&#xD;
&#xD;
          -  Any requirement for urgent surgical evacuation is necessary.&#xD;
&#xD;
          -  Life expectancy is less than 6 months in the opinion of the subject's primary&#xD;
             physician.&#xD;
&#xD;
          -  Markedly tortuous vasculature precluding safe endovascular access, as assessed on&#xD;
             angiogram.&#xD;
&#xD;
          -  Acute subdural hematomas.&#xD;
&#xD;
          -  Pregnancy&#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>Jared Knopman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Subdural Hematoma</keyword>
  <keyword>Embolization</keyword>
  <keyword>Middle meningeal artery</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>Yes</sharing_ipd>
    <ipd_description>De-identified participant data for primary and secondary outcome measures will be available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available within one year of study completion</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the PI.</ipd_access_criteria>
  </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/NCT03307395
org study id: 1611017746
nct id: NCT03307395
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has
      been attempted with the goal of eliminating the arterial supply to the vascularized membrane.
      The investigators have recently presented the first known case series of MMA embolization as
      upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five
      patients underwent successful embolization of the MMA with subsequent reduction in size or
      complete resolution of cSDH with no peri-procedural complications.

      The purpose of this study will be to evaluate the safety and efficacy of MMA embolization
      compared to traditional surgical management for symptomatic, chronic, and medically
      refractory SDH. MMA embolization is an established procedure used routinely for treatment of
      tumors or vascular malformations; this study investigates the use of an established procedure
      for a new disease. The investigators hypothesize that MMA embolization will afford a
      particularly fragile patient population an alternative to invasive and morbid neurosurgical
      intervention.
The purpose of this study will be to evaluate the safety and efficacy of middle meningeal
      artery (MMA) embolization compared to traditional surgical management for symptomatic,
      chronic, and medically refractory subdural hematoma (SDH). MMA embolization is an established
      procedure used routinely for treatment of tumors or vascular malformations; this study
      investigates the use of an established procedure for a new disease. The investigators
      hypothesize that MMA embolization will afford a particularly fragile patient population an
      alternative to invasive and morbid neurosurgical intervention.

      Since subjects being enrolled will be those that are symptomatic from chronic SDH,
      pre-procedural data such as clinical history, neurologic examination, and CT scans will
      already be available. The day after the embolization, subjects will undergo a clinical
      interview to assess change in symptoms. A neurologic exam and CT scan will also be performed
      prior to discharge. Telephone surveys will be used at intermittent time points to assess for
      change in clinical symptoms. The subjects will also present in clinic for a follow up
      clinical interview, neurologic exam, and CT scan at 2 and 6 weeks post-procedure. This follow
      up care including the CT scans is considered standard of care for patients undergoing surgery
      for chronic SDH and it will not expose them to any additional tests or imaging studies.

      MMA embolization is done under moderate sedation or general anesthesia using biplane
      fluoroscopy. Briefly, common femoral artery access is obtained, and a guide catheter is
      advanced into the external carotid artery. A microcatheter is then advanced into the internal
      maxillary artery and then the MMA. Particles are then injected. A post-procedure carotid
      angiography is performed to ensure no reflux of particles into the internal carotid artery
      circulation. The guide catheter is then removed and femoral hemostasis is obtained. Subjects
      recover from anesthesia and are observed overnight, undergo a non-contrast head CT the next
      day, and discharged if appropriate.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in neurological status after embolization of the MMA for symptomatic, chronic, and medically refractory SDH.
time frame: The neurological exam will be performed before the procedure, the day after the procedure, and at 2 and 6 weeks post-procedure to assess any changes in neurological status.
description: A neurological exam will be performed to assess any neurological changes post-procedure.
measure: Changes in size of the SDH post-procedure.
time frame: A head CT will be performed to assess the size of the SDH post-procedure. This will occur before the procedure, the day after the procedure, and at 2 and 6 weeks post-procedure.
description: A CT scan will be performed to assess the size of the SDH before and after the procedure.
measure: The safety of embolization of the MMA for symptomatic, chronic, and medically refractory SDH
time frame: Pre-procedure, 1 day post-procedure, and 2 and 6 weeks post-procedure.
description: A neurologic exam will be performed to assess any neurological deficits and/or improvements post-procedure.
arm group label: Middle Meningeal Artery Embolization
arm group type: Experimental
intervention type: Procedure
intervention name: Middel Meningeal Artery Embolization
description: Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.
arm group label: Middle Meningeal Artery Embolization
other name: MMA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jared Knopman, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Chronic
mesh term: Hematoma
sharing ipd: Yes
ipd description: De-identified participant data for primary and secondary outcome measures will be available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available within one year of study completion
ipd access criteria: Data access requests will be reviewed by the PI.