<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/NCT01663896</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CVD-0612</org_study_id>
    <nct_id>NCT01663896</nct_id>
  </id_info>
  <brief_title>Observational Study of OCT in a Patients Undergoing FFR</brief_title>
  <acronym>ILUMIEN I</acronym>
  <official_title>Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent&#xD;
      guidance parameters through prospective data collection in percutaneous coronary intervention&#xD;
      (PCI) procedures of de novo lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optical coherence tomography (OCT) is an imaging modality that uses near-infrared light to&#xD;
      produce high resolution, real-time images that are clearer and more quickly produced than&#xD;
      those produced by intravascular ultrasound (IVUS). OCT imaging is performed utilizing an&#xD;
      imaging catheter with a single optical fiber core that both emits light and records its&#xD;
      reflection while simultaneously rotating 360° during continuous pullback within the coronary&#xD;
      artery. Fractional Flow Reserve (FFR) is a pressure-derived, lesion-specific, physiological&#xD;
      index determining the hemodynamic severity of intracoronary lesions. FFR is measured by&#xD;
      placing a pressure guidewire across the lesion of interest and pharmacologically inducing&#xD;
      hyperemia. The ratio of distal to proximal pressure allows the physician to physiologically&#xD;
      determine if the narrowing is the cause of ischemia. the goal of this study is to define new&#xD;
      parameters for stent optimization, benefitting from the unique Fourier-domain (FD-OCT)&#xD;
      capabilities.&#xD;
&#xD;
      This stage I study will identify the parameters which will be prospectively tested in a&#xD;
      second stage II protocol.&#xD;
&#xD;
      In hospital, 30 day, and 12 month outcomes data will be correlated with OCT baseline findings&#xD;
      in order to identify optimal stent implant parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">March 12, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting</measure>
    <time_frame>In-hospital until discharge</time_frame>
    <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting</measure>
    <time_frame>30 Days</time_frame>
    <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT</measure>
    <time_frame>1 Year</time_frame>
    <description>Assessment of OCT on Physician Decision Making includes:&#xD;
Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment&#xD;
OCT parameters as assessed by Core Lab</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">418</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Single or multi vessel disease</arm_group_label>
    <description>Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCT stent guidance</intervention_name>
    <description>Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT</description>
    <arm_group_label>Single or multi vessel disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elective or ad hoc PCI, stable angina, acute coronary syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years.&#xD;
&#xD;
          2. Patient provides signed written informed consent before any study-specific procedure.&#xD;
&#xD;
          3. De novo coronary artery disease in target vessel.&#xD;
&#xD;
          4. Single or multi vessel disease. For multi vessel disease up to two vessels and three&#xD;
             lesions treated, with no more than two lesions per vessel. Vessel is defined as, left&#xD;
             anterior descending, left circumflex, and right coronary arteries. Any branch within&#xD;
             the vessel is considered part of the vessel.&#xD;
&#xD;
          5. Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and&#xD;
             NSTEMI).&#xD;
&#xD;
          6. Angiographically significant (&gt;50% visual estimation) stenosis present in at least one&#xD;
             native coronary artery.&#xD;
&#xD;
          7. Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects&#xD;
             with an FFR ≤ 0.80 in target vessel.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with STEMI, emergent PCI, or in cardiogenic shock.&#xD;
&#xD;
          2. Subjects with target left main lesion.&#xD;
&#xD;
          3. Subjects with restenosis or stent thrombosis in the target vessel.&#xD;
&#xD;
          4. Planned use of bare metal stent.&#xD;
&#xD;
          5. Known renal insufficiency (examples being but not limited to eGFR &lt; 60 ml/kg/m2, serum&#xD;
             creatinine ≥ 2.5 mg/dL, or on dialysis).&#xD;
&#xD;
          6. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).&#xD;
&#xD;
          7. Extreme angulation (&gt; 90°) or excessive tortuosity (&gt; two 45° angles) proximal to or&#xD;
             within the target lesion.&#xD;
&#xD;
          8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.&#xD;
&#xD;
          9. Any other medical condition that in the opinion of the investigator will interfere&#xD;
             with patient safety or study results.&#xD;
&#xD;
         10. Currently participating in another clinical study that interferes with study results.&#xD;
&#xD;
         11. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year&#xD;
             following index procedure.&#xD;
&#xD;
         12. Life expectancy less than 1 year.&#xD;
&#xD;
         13. Potential for non-compliance to protocol requirements and follow-up.&#xD;
&#xD;
         14. Planned or prior heart transplantation or listed for heart transplant.&#xD;
&#xD;
         15. Any condition that precludes the subject from undergoing PCI, for example subjects&#xD;
             with heparin induced thrombocytopenia, or contrast allergy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital - Univ. of Alabama at Birmingham (UAB)</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Clinic, Green Hospital</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Chicago</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Baptist Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health East</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital/Mid America Heart</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cardiovascular Institute</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Hospital of Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas VA Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch at Galveston</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora St. Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med. Univ. Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OLV Hospital</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gasthuisberg Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Brno</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHC du Marie Lannelongue</name>
      <address>
        <city>Le Plessis Robinson</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti di Bergamo</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giovanni Addolorata</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Graduate School of Medicine</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nara Medical University Hospital</name>
      <address>
        <city>Nara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Saiseikai Nakatsu Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxcentre Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>June 22, 2016</results_first_submitted>
  <results_first_submitted_qc>June 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2020</results_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCT, FFR, percutaneous coronary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Initially a total of 1069 subjects gave consent from 36 investigational sites, of which 418 qualified subjects completed enrollment in February 2014 at 35 investigational sites. First subject was enrolled on Dec 11, 2012 and the last subject completed the 12 month follow-up on Mar 12, 2015.</recruitment_details>
      <pre_assignment_details>Of the 1069 subjects, 616 were failed to screen and 35 were not qualified for inclusion. Thus 418 subjects underwent pre-intervention fractional flow reserve (FFR) and optical coherence tomography (OCT), percutaneous coronary intervention (PCI), and post intervention FFR and OCT. The subjects were followed up through 12 month post stent implant.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Optical Coherence Tomography (OCT)</title>
          <description>Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="418"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="375"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Various reasons</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Optical Coherence Tomography (OCT)</title>
          <description>Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="418"/>
          </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="64.7" spread="10.2"/>
                  </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="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting</title>
        <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.</description>
        <time_frame>In-hospital until discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Optical Coherence Tomography (OCT)</title>
            <description>A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting</title>
          <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.</description>
          <units>Percentage of per-subject incidence</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="418"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Device-oriented MACE (Cardiac death)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(MI-AEC definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(MI-3rd Universal definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(TLR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(All-cause mortality)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(MI-ARC Definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(MI-3rd Universal definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(Any Revascularization)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Definite)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Probable)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Possible)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Early)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Late)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Very Late)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting</title>
        <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days</description>
        <time_frame>30 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Optical Coherence Tomography (OCT)</title>
            <description>A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting</title>
          <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days</description>
          <units>Percentage of per-subject incidence</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="416"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Device-oriented MACE (Cardiac death)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(MI-AEC definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(MI-3rd Universal definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(TLR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(All-cause mortality)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(MI-ARC Definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(MI-3rd Universal definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(Any Revascularization)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Definite)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Probable)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Possible)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Early)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Late)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Very Late)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))</title>
        <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Optical Coherence Tomography (OCT)</title>
            <description>A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))</title>
          <description>Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months</description>
          <units>Percentage of per-subject incidence</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Device-oriented MACE (Cardiac death)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(MI-AEC definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(MI-3rd Universal definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device-oriented MACE(TLR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(All-cause mortality)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(MI-ARC Definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(MI-3rd Universal definition)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient-oriented MACE(Any Revascularization)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Definite)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Probable)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Possible)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Early)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Late)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Thrombosis(Very Late)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT</title>
        <description>Assessment of OCT on Physician Decision Making includes:&#xD;
Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment&#xD;
OCT parameters as assessed by Core Lab</description>
        <time_frame>1 Year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Optical Coherence Tomography (OCT)</title>
            <description>Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT</title>
          <description>Assessment of OCT on Physician Decision Making includes:&#xD;
Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment&#xD;
OCT parameters as assessed by Core Lab</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="418"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Procedure Planning(Pre-PCI OCT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Procedure Planning(Post-PCI OCT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician decision-making (Pre-PCI OCT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician decision-making (Post-PCI OCT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1-Year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Optical Coherence Tomography (OCT)</title>
          <description>Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 11.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="112" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemias</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Atrioventricular (AV) Dissociation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Cardiovascular Deconditioning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Heart Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Left Bundle Branch Block/Complete Left Bundle Branch Block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Pericardial Tamponade</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Third Degree Heart Block (Complete Heart Block)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Unstable Angina</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Ventricular Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual Disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Acute Erosive Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Emesis/Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Gingival Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Melena</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Pneumonia in the Compromised Host</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Side Branch Compromise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Abnormal Lab Value</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>EKG Abnormalities</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Echo Finding</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Knee Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Colon Polyps</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Lung Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Intracerebral Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Ischemic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Non-Endpoint Transient Ischemic Attack (TIA)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease (COPD)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 10.0">Idiopathic Interstitial Lung Diseases</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Elective Surgery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial Hypertension/Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>VASC Vessel Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Vessel Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 11.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="128" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemias</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Iron-Deficiency Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hypokinetic Septal Motion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Mitral Valve Regurgitation/Mitral Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 10.0">Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Premature Ventricular Contraction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia</sub_title>
                <description>Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia includes: Other - Non-sustained runs of VT, Ventricular Ectopic Beats/Premature Ventricular Contractions/Premature Ventricular Beats</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 10.0">Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Dry Eyes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Eye Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Visual Disturbance</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hiatus Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Ingestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Viral Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 10.0">Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Apnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Callus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Chest Tightness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Fatigue/Generalized Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hip Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Knee Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Lacerations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Melena</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Myalgias</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Obstructive Sleep Apnea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Post-Nasal Drainage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Common Cold/Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Rib Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Trauma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Abnormal Lab Value</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>EKG Abnormalities</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Peak T Waves</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arm Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Arm Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Low Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Muscle Strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Wrist Sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal Tunnel</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Fainting/Blackout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Vaso Vagal Response</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infections</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease (COPD)</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Difficulty Catching Breath</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bruise/Purpura Simplex</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Skin Bruise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Skin Lesions</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Aneurysms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Arterial Hypertension/Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Arteriovenous (AV) Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Renal Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Thrombus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>VASC Bruise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>VASC Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>VASC Pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>VASC Vessel Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="418"/>
              </event>
              <event>
                <sub_title>Vessel Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="418"/>
              </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>Proposals for all publications, abstracts, presentations, or journal manuscripts arising from, or related to the Study will be submitted for approval to the Publications Committee. Accordingly, decisions on timing and content of publications and presentations from the Study will be coordinated with the Study Publication Committee and Sponsor.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Patients with acute STEMI, left main PCI, severe chronic kidney disease, and other high-risk features were excluded. No prescriptive recommendations were provided in the protocol, a wide variation in physician behavior was expected and observed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sr. Manager, Global Clinical Affairs</name_or_title>
      <organization>St. Jude Medical</organization>
      <phone>651-756-5585</phone>
      <email>mwagner2@sjm.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/NCT01663896
org study id: SJM-CVD-0612
nct id: NCT01663896
lead sponsor: 
has dmc: Yes
The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent
      guidance parameters through prospective data collection in percutaneous coronary intervention
      (PCI) procedures of de novo lesions.
Optical coherence tomography (OCT) is an imaging modality that uses near-infrared light to
      produce high resolution, real-time images that are clearer and more quickly produced than
      those produced by intravascular ultrasound (IVUS). OCT imaging is performed utilizing an
      imaging catheter with a single optical fiber core that both emits light and records its
      reflection while simultaneously rotating 360° during continuous pullback within the coronary
      artery. Fractional Flow Reserve (FFR) is a pressure-derived, lesion-specific, physiological
      index determining the hemodynamic severity of intracoronary lesions. FFR is measured by
      placing a pressure guidewire across the lesion of interest and pharmacologically inducing
      hyperemia. The ratio of distal to proximal pressure allows the physician to physiologically
      determine if the narrowing is the cause of ischemia. the goal of this study is to define new
      parameters for stent optimization, benefitting from the unique Fourier-domain (FD-OCT)
      capabilities.

      This stage I study will identify the parameters which will be prospectively tested in a
      second stage II protocol.

      In hospital, 30 day, and 12 month outcomes data will be correlated with OCT baseline findings
      in order to identify optimal stent implant parameters.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
time frame: In-hospital until discharge
description: Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
measure: Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
time frame: 30 Days
description: Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
measure: Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
time frame: 12 months
description: Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
measure: Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
time frame: 1 Year
description: Assessment of OCT on Physician Decision Making includes:
Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment
OCT parameters as assessed by Core Lab
arm group label: Single or multi vessel disease
description: Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.
intervention type: Device
intervention name: OCT stent guidance
description: Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
arm group label: Single or multi vessel disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Austria
country: Belgium
country: Canada
country: China
country: Czechia
country: France
country: Germany
country: Italy
country: Japan
country: Netherlands
country: Spain
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Patients with acute STEMI, left main PCI, severe chronic kidney disease, and other high-risk features were excluded. No prescriptive recommendations were provided in the protocol, a wide variation in physician behavior was expected and observed.
point of contact: 