<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/NCT01684826</url>
  </required_header>
  <id_info>
    <org_study_id>XCY607-100084</org_study_id>
    <nct_id>NCT01684826</nct_id>
  </id_info>
  <brief_title>X-ray Dose Reduction Study for Cardiac Angiography and Intervention</brief_title>
  <official_title>Clinical Validation and Evaluation of ClarityIQ Cardiac Image Processing for Cardiac Angiography and Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Clinical &amp; Medical Affairs Global</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Clinical &amp; Medical Affairs Global</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise&#xD;
      reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose&#xD;
      significantly. This is realized by anatomy-specific optimization of the full acquisition&#xD;
      chain (grid switch, beam filtering, pulse width, spot size, detector and image processing&#xD;
      engine) for every clinical task individually. Furthermore, smaller focal spot sizes and&#xD;
      shorter pulses are used, which are known to positively influence image quality . The final&#xD;
      effect on the clinical image quality is investigated in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fluoroscopically guided procedures are associated with a risk of radiation injury to the&#xD;
      skin, caused by high peak skin dose. The increasingly complex nature of many of the&#xD;
      interventions performed requires the use of significant amounts of radiation for their&#xD;
      completion. Of particular relevance to dose reduction concerns are obese patients, for whom&#xD;
      additional radiation is often necessary to obtained sufficient diagnostic quality, as well as&#xD;
      patients suffering from chronic total coronary occlusions (CTO), for whom long procedures&#xD;
      with extended radiation time and contrast usage are common.&#xD;
&#xD;
      In order to introduce a dose reduction technology the most important aspect is to validate&#xD;
      the diagnostic image information. Philips has developed a new algorithm that is capable to&#xD;
      process images with similar image quality but acquired at lower dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Image Quality</measure>
    <time_frame>1 day</time_frame>
    <description>Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.&#xD;
The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose Measurements: Dose Area Product (DAP)</measure>
    <time_frame>Participants were followed for the duration of the procedure</time_frame>
    <description>Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Radiation Dose Measurements: Air Kerma (AK)</measure>
    <time_frame>Participants were followed for the duration of the procedure</time_frame>
    <description>Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Vascular Diseases</condition>
  <arm_group>
    <arm_group_label>ClarityIQ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Angiographic run with new algorithm and low dose (50% dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AlluraXper</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Angiographic run with predecessor algorithm and dose (100% dose)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Angiographic run with new algorithm and low dose (50% dose)</intervention_name>
    <description>Angiographic run with new algorithm and low dose (50% lower dose compared to Xper)</description>
    <arm_group_label>ClarityIQ</arm_group_label>
    <other_name>ClarityIQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Angiographic run with predecessor algorithm and dose (100%)</intervention_name>
    <description>Angiographic run with predecessor algorithm and dose (100% dose)</description>
    <arm_group_label>AlluraXper</arm_group_label>
    <other_name>AlluraXper</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years of age undergoing coronary angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not willing or unable to give consent to participate&#xD;
&#xD;
          -  Patients already involved in a clinical trial&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Pregnant women and breastfeeding women&#xD;
&#xD;
          -  Patients with severe kidney disease (eGFR &lt; 60)&#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>Harry Suryapranata, Prof Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Nijmegen Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <results_first_submitted>August 26, 2013</results_first_submitted>
  <results_first_submitted_qc>August 26, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 1, 2013</results_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>X-rays</keyword>
  <keyword>Image processing</keyword>
  <keyword>Cardiovascular procedure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The enrollment of patients occurred between 11 September and 23 November 2012.</recruitment_details>
      <pre_assignment_details>50 patients enrolled the study one subject withdrew consent.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AlluraXper-ClarityIQ</title>
          <description>Angiogram with AlluraXper followed by angiogram with ClarityIQ</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Collected Dose and Image Information</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AlluraXper-ClarityIQ</title>
          <description>Angiogram with AlluraXper followed by angiogram with ClarityIQ</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.8" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Image Quality</title>
        <description>Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.&#xD;
The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used.</description>
        <time_frame>1 day</time_frame>
        <population>All patient with recorded dose information and images for both angiograms were used.</population>
        <group_list>
          <group group_id="O1">
            <title>AlluraXper-ClarityIQ</title>
            <description>Angiogram with AlluraXper followed by angiogram with ClarityIQ</description>
          </group>
        </group_list>
        <measure>
          <title>Image Quality</title>
          <description>Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.&#xD;
The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used.</description>
          <population>All patient with recorded dose information and images for both angiograms were used.</population>
          <units>proportion of readers</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" lower_limit="0.82" upper_limit="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose Measurements: Dose Area Product (DAP)</title>
        <description>Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.</description>
        <time_frame>Participants were followed for the duration of the procedure</time_frame>
        <population>all patients with recorded dose information and images for both angiograms were included (n=39)</population>
        <group_list>
          <group group_id="O1">
            <title>AlluraXper-ClarityIQ</title>
            <description>Angiogram with AlluraXper followed by angiogram with ClarityIQ</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose Measurements: Dose Area Product (DAP)</title>
          <description>Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.</description>
          <population>all patients with recorded dose information and images for both angiograms were included (n=39)</population>
          <units>percentage of dose change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-52" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Radiation Dose Measurements: Air Kerma (AK)</title>
        <description>Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.</description>
        <time_frame>Participants were followed for the duration of the procedure</time_frame>
        <population>all patients with recorded dose information and images for both angiograms were included (n=39)</population>
        <group_list>
          <group group_id="O1">
            <title>AlluraXper-ClarityIQ</title>
            <description>Angiogram with AlluraXper followed by angiogram with ClarityIQ</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose Measurements: Air Kerma (AK)</title>
          <description>Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.</description>
          <population>all patients with recorded dose information and images for both angiograms were included (n=39)</population>
          <units>percentage of dose change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AlluraXper-ClarityIQ</title>
          <description>Angiogram with AlluraXper followed by angiogram with ClarityIQ</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ventricle Fibrillations (VF)</sub_title>
                <description>defibrillation is done with 150 J</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Type 2 Aorta dissection</sub_title>
                <description>patient has atypical complaints. Suspected ACS. Troponin negative. Bloodpressure declines. Remaining contrast extra vasal (contrast injection in false lumen). Emergency CT scan made. Confirmed Aorta Dissection. Patient underwent emergency surgery.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Frank Everaerts</name_or_title>
      <organization>Philips</organization>
      <phone>+31630728782</phone>
      <email>frank.everaerts@philips.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01684826
org study id: XCY607-100084
nct id: NCT01684826
lead sponsor: 
has dmc: No
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise
      reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose
      significantly. This is realized by anatomy-specific optimization of the full acquisition
      chain (grid switch, beam filtering, pulse width, spot size, detector and image processing
      engine) for every clinical task individually. Furthermore, smaller focal spot sizes and
      shorter pulses are used, which are known to positively influence image quality . The final
      effect on the clinical image quality is investigated in this study.
Fluoroscopically guided procedures are associated with a risk of radiation injury to the
      skin, caused by high peak skin dose. The increasingly complex nature of many of the
      interventions performed requires the use of significant amounts of radiation for their
      completion. Of particular relevance to dose reduction concerns are obese patients, for whom
      additional radiation is often necessary to obtained sufficient diagnostic quality, as well as
      patients suffering from chronic total coronary occlusions (CTO), for whom long procedures
      with extended radiation time and contrast usage are common.

      In order to introduce a dose reduction technology the most important aspect is to validate
      the diagnostic image information. Philips has developed a new algorithm that is capable to
      process images with similar image quality but acquired at lower dose.
allocation: Non-Randomized
primary purpose: Treatment
masking: None (Open Label)
measure: Image Quality
time frame: 1 day
description: Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.
The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used.
measure: Radiation Dose Measurements: Dose Area Product (DAP)
time frame: Participants were followed for the duration of the procedure
description: Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.
measure: Radiation Dose Measurements: Air Kerma (AK)
time frame: Participants were followed for the duration of the procedure
description: Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.
arm group label: ClarityIQ
arm group type: Experimental
description: Angiographic run with new algorithm and low dose (50% dose)
arm group label: AlluraXper
arm group type: Experimental
description: Angiographic run with predecessor algorithm and dose (100% dose)
intervention type: Radiation
intervention name: Angiographic run with new algorithm and low dose (50% dose)
description: Angiographic run with new algorithm and low dose (50% lower dose compared to Xper)
arm group label: ClarityIQ
other name: ClarityIQ
intervention type: Radiation
intervention name: Angiographic run with predecessor algorithm and dose (100%)
description: Angiographic run with predecessor algorithm and dose (100% dose)
arm group label: AlluraXper
other name: AlluraXper
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harry Suryapranata, Prof Dr.
role: Principal Investigator
affiliation: Radboud University Nijmegen Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Vascular Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 