<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/NCT03232151</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0482</org_study_id>
    <secondary_id>1U01EB021183-01</secondary_id>
    <secondary_id>A539300</secondary_id>
    <secondary_id>SMPH\RADIOLOGY\RADIOLOGY</secondary_id>
    <secondary_id>Protocol Version 3/27/2020</secondary_id>
    <nct_id>NCT03232151</nct_id>
  </id_info>
  <brief_title>C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions</brief_title>
  <official_title>C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions Evaluating Predictability and Accuracy for the Treatment of Acute Cerebral Ischemia in the Angiography Suite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the&#xD;
      available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently&#xD;
      widely available worldwide in interventional angiography suites to enable acute ischemic&#xD;
      stroke patients to be imaged, triaged, treated, and assessed using a single modality in one&#xD;
      room.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an evaluation to determine the efficacy of the use of C-arm CBCT with SMART RECON&#xD;
      novel software for the rapid assessment of time-resolved CTA and CT perfusion in the setting&#xD;
      of ischemic cerebrovascular events. As a leading center for the treatment of cerebrovascular&#xD;
      disease in the Midwest as well as being one of the first Comprehensive Stroke Centers in the&#xD;
      United States we have a large potential patient group to assess.&#xD;
&#xD;
      The pilot plan is to compare conventional CT/CTA/CTP acquired during the clinical work up&#xD;
      with C-arm CBCT/CTA/CTP acquired in the angiography suite at initiation of therapy. The C-arm&#xD;
      CBCT acquisition provides whole brain coverage (compared to only 8 cm brain coverage with&#xD;
      conventional CT) with less radiation and higher resolution; the CT perfusion maps obtained&#xD;
      using C-arm CBCT and new reconstruction algorithms provides better perfusion maps.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 26, 2020</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>
    <intervention_model_description>Single center, open label, single-arm, pilot study</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT</measure>
    <time_frame>1 study visit up to 1 hour</time_frame>
    <description>To demonstrate device feasibility for phase 2 of this study, the investigators need to demonstrate that the presence of hyperemia or oligemia detected with standard of care conventional CT is also detected to a clinically acceptable degree with C-arm Cone Beam CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optimization of One-Stop-Shop Imaging</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Data collected will be used to optimize C-arm CBCT imaging parameters, data acquisition methods and contrast dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Perfusion Parameters from One-Stop-Shop Perfusion Maps</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Local perfusion parameters on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of ROIs from One-Stop-Shop Perfusion Maps</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Standard deviations for a variety of regions of interest (ROIs) on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>C-ARM CBCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A C-arm CBCT evaluation with SMART RECON novel software for the rapid assessment of time-resolved CT angiogram and CT perfusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>C-Arm Cone Beam Computed Tomography</intervention_name>
    <description>C-ARM CBCT angiogram and CBCT perfusion imaging using prototype software (SMART-RECON) can rapidly and accurately assess the cerebral blood flow maps in the setting of decreased blood flow to the brain (ischemic cerebrovascular events). This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the angiography suite.</description>
    <arm_group_label>C-ARM CBCT</arm_group_label>
    <other_name>C-ARM CBCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with acute ischemic stroke presenting within 8 hours of onset&#xD;
&#xD;
          2. Patients that present with a large artery occlusion&#xD;
&#xD;
          3. Adults 18 years of age or older.&#xD;
&#xD;
          4. Women of childbearing potential must not be pregnant.&#xD;
&#xD;
          5. National Institutes of Health Stroke Scale (NIHSS) of &gt;5&#xD;
&#xD;
          6. No severe co-morbidities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women that are pregnant&#xD;
&#xD;
          2. History of severe renal disease (e.g. stage 4-5)&#xD;
&#xD;
          3. History of renal transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beverly Aagaard-Kienitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin, Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</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/NCT03232151
org study id: 2015-0482
secondary id: 1U01EB021183-01
secondary id: A539300
secondary id: SMPH\RADIOLOGY\RADIOLOGY
secondary id: Protocol Version 3/27/2020
nct id: NCT03232151
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the
      available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently
      widely available worldwide in interventional angiography suites to enable acute ischemic
      stroke patients to be imaged, triaged, treated, and assessed using a single modality in one
      room.
This is an evaluation to determine the efficacy of the use of C-arm CBCT with SMART RECON
      novel software for the rapid assessment of time-resolved CTA and CT perfusion in the setting
      of ischemic cerebrovascular events. As a leading center for the treatment of cerebrovascular
      disease in the Midwest as well as being one of the first Comprehensive Stroke Centers in the
      United States we have a large potential patient group to assess.

      The pilot plan is to compare conventional CT/CTA/CTP acquired during the clinical work up
      with C-arm CBCT/CTA/CTP acquired in the angiography suite at initiation of therapy. The C-arm
      CBCT acquisition provides whole brain coverage (compared to only 8 cm brain coverage with
      conventional CT) with less radiation and higher resolution; the CT perfusion maps obtained
      using C-arm CBCT and new reconstruction algorithms provides better perfusion maps.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single center, open label, single-arm, pilot study
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT
time frame: 1 study visit up to 1 hour
description: To demonstrate device feasibility for phase 2 of this study, the investigators need to demonstrate that the presence of hyperemia or oligemia detected with standard of care conventional CT is also detected to a clinically acceptable degree with C-arm Cone Beam CT.
measure: Optimization of One-Stop-Shop Imaging
time frame: Up to 24 months
description: Data collected will be used to optimize C-arm CBCT imaging parameters, data acquisition methods and contrast dose.
measure: Analysis of Perfusion Parameters from One-Stop-Shop Perfusion Maps
time frame: Up to 24 months
description: Local perfusion parameters on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.
measure: Analysis of ROIs from One-Stop-Shop Perfusion Maps
time frame: Up to 24 months
description: Standard deviations for a variety of regions of interest (ROIs) on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.
arm group label: C-ARM CBCT
arm group type: Experimental
description: A C-arm CBCT evaluation with SMART RECON novel software for the rapid assessment of time-resolved CT angiogram and CT perfusion.
intervention type: Diagnostic Test
intervention name: C-Arm Cone Beam Computed Tomography
description: C-ARM CBCT angiogram and CBCT perfusion imaging using prototype software (SMART-RECON) can rapidly and accurately assess the cerebral blood flow maps in the setting of decreased blood flow to the brain (ischemic cerebrovascular events). This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the angiography suite.
arm group label: C-ARM CBCT
other name: C-ARM CBCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Beverly Aagaard-Kienitz, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ischemic Stroke
sharing ipd: No