<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/NCT02996877</url>
  </required_header>
  <id_info>
    <org_study_id>ISROTH10299</org_study_id>
    <nct_id>NCT02996877</nct_id>
  </id_info>
  <brief_title>Outcomes of Surgically Ineligible Patients With Multivessel CAD</brief_title>
  <acronym>OPTIMUM</acronym>
  <official_title>Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease: A Prospective Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Luke's Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Piedmont Heart Institute, Inc., Atlanta, GA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Saint Luke's Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort&#xD;
      design to follow patients who have multivessel or left main coronary artery disease&#xD;
      (&quot;surgical anatomy&quot; according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed&#xD;
      ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be&#xD;
      selected to participate in the registry from a national network of leading centers across the&#xD;
      United States with recognized expertise in both complex PCI and coronary artery bypass&#xD;
      surgery. We will invite leading cardiac centers, as defined by US News and World reports&#xD;
      rankings for heart care. Additional sites may be added to meet the target enrollment goal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives 1. Compare 30-day mortality and the composite of mortality and morbidity following&#xD;
      high-risk percutaneous coronary revascularization with predicted Society of Thoracic Surgeons&#xD;
      (STS) survival and morbidity in patients with severe multivessel or left main coronary artery&#xD;
      disease (CAD).&#xD;
&#xD;
      2. Compare the 12-month health status and clinical outcomes of surgically ineligible&#xD;
      multivessel or left main CAD patients treated with PCI compared to those treated with a&#xD;
      medical therapy alone.&#xD;
&#xD;
      3. Understand the association between completeness of revascularization and long-term health&#xD;
      status and clinical outcomes among patients with multivessel or left main CAD treated with&#xD;
      PCI deemed ineligible for surgery.&#xD;
&#xD;
      4. Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients&#xD;
      with predicted STS survival (ASCERT risk model)&#xD;
&#xD;
      5. Determine the justification for surgical ineligibility by cardiologists and cardiac&#xD;
      surgeons among patients with severe multivessel or left main coronary artery disease (CAD).&#xD;
&#xD;
      6. Describe the frequency and predictors of PCI versus medical management among surgically&#xD;
      ineligible patients with severe multivessel or left main CAD.&#xD;
&#xD;
      7. Describe the frequency and predictors of complete revascularization in this population.&#xD;
&#xD;
      8. Describe the costs and costs per quality adjusted life year (QALY) gained of the strategy&#xD;
      of management of multivessel or left main CAD with PCI versus medical therapy among&#xD;
      surgically ineligible patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>30 day survival following high risk percutaneous coronary revascularization who are at high risk.</measure>
    <time_frame>30 days</time_frame>
    <description>Patients will be followed with phone calls at 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only.</measure>
    <time_frame>12 months</time_frame>
    <description>Patients will be called at 12 months time by the centralized follow up center.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">750</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Guideline Directed Medical Therapy</arm_group_label>
    <description>Patients who have an initial treatment strategy of using guideline-directed medical therapy only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Percutaneous Coronary Intervention</arm_group_label>
    <description>Patients who will have a Percutaneous Coronary Intervention as the initial treatment strategy along with guideline directed medical therapy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients identified as having Coronary Artery Disease with Left Main or multivessel&#xD;
        involvement, who have been deemed ineligible to receive coronary bypass surgery as&#xD;
        treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Participant Selection Inclusion Criteria&#xD;
&#xD;
          1. Participant undergoes coronary angiography revealing unprotected left main stenosis of&#xD;
             &gt; 50%, 3 vessel disease with stenoses &gt; 70% or 2 vessel coronary disease (&gt;70%) with&#xD;
             one lesion involving the proximal LAD. Patients will also be included if there is FFR&#xD;
             evidence of flow limiting stenosis (FFR ≤ 0.80) in the setting of &gt; 40% angiographic&#xD;
             stenosis the left main, 3 epicardial coronaries or 2 vessels including the proximal&#xD;
             LAD. Patients with prior bypass surgery will be included if they have ≥ 2 epicardial&#xD;
             vascular distributions subtended by a severe native coronary stenosis with either no&#xD;
             bypass graft supplying the vessel, a severely diseased (&gt;70% stenosis) bypass graft&#xD;
             supplying the affected vessel or an occluded bypass graft to the affected vessel.&#xD;
&#xD;
          2. Patient considered high risk for coronary artery bypass surgery and declared&#xD;
             ineligible for surgery by the heart team.&#xD;
&#xD;
          3. Patient is experiencing clinical symptoms consistent with obstructive coronary artery&#xD;
             disease or with evidence of coronary ischemia on non-invasive/invasive (FFR)&#xD;
             functional testing.&#xD;
&#xD;
          4. Subject is ≥ 18 years of age at the time of consent and is willing to sign an informed&#xD;
             consent document approved by the enrolling hospital's Institutional Review Board and&#xD;
             follow-up for 12-months following enrollment in the study&#xD;
&#xD;
          5. Patient is able to speak English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion Criteria&#xD;
&#xD;
               1. Established iodine allergy that cannot be managed medically, allergy to&#xD;
                  everolimus, or absolute contraindication to aspirin, P2Y12 antagonist therapy&#xD;
                  with either clopidogrel, prasgurel, ticagrelor or ticlopidine or absolute&#xD;
                  contraindication to bivalirudin and heparin precluding procedural&#xD;
                  anticoagulation.&#xD;
&#xD;
               2. Emergent revascularization required for ST-elevation myocardial infarction or&#xD;
                  cardiac arrest, or severe sustained hemodynamic instability.&#xD;
&#xD;
               3. Patients presenting late after STEMI (&gt; 12 hours after symptom onset) for&#xD;
                  &quot;salvage&quot; PCI.&#xD;
&#xD;
               4. Too hard of hearing to do follow-up by telephone.&#xD;
&#xD;
               5. Currently incarcerated.&#xD;
&#xD;
               6. Dementia.&#xD;
&#xD;
               7. Subjects with no way to be contacted by telephone for follow-up, including those&#xD;
                  who live outside of the U.S. or spend significant time outside of the U.S.&#xD;
&#xD;
               8. Patients with conditions such as cancer, mental illness, or other pathology&#xD;
                  which, in the opinion of the local investigator, might put the patient at risk,&#xD;
                  preclude follow-up or confound the results of the study.&#xD;
&#xD;
               9. Patients who refuse.&#xD;
&#xD;
              10. Female subjects with a positive quantitative or qualitative pregnancy test will&#xD;
                  not be enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam C Salisbury, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Luke's Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David E Kandzari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Piedmont Heart and Vascular Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James A Grantham, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Luke's Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unifersity of California San Diego Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health System</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columiba University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Health System</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Area Medical Center</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996877
org study id: ISROTH10299
nct id: NCT02996877
lead sponsor: 
collaborator: 
has dmc: No
The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort
      design to follow patients who have multivessel or left main coronary artery disease
      ("surgical anatomy" according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed
      ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be
      selected to participate in the registry from a national network of leading centers across the
      United States with recognized expertise in both complex PCI and coronary artery bypass
      surgery. We will invite leading cardiac centers, as defined by US News and World reports
      rankings for heart care. Additional sites may be added to meet the target enrollment goal.
Objectives 1. Compare 30-day mortality and the composite of mortality and morbidity following
      high-risk percutaneous coronary revascularization with predicted Society of Thoracic Surgeons
      (STS) survival and morbidity in patients with severe multivessel or left main coronary artery
      disease (CAD).

      2. Compare the 12-month health status and clinical outcomes of surgically ineligible
      multivessel or left main CAD patients treated with PCI compared to those treated with a
      medical therapy alone.

      3. Understand the association between completeness of revascularization and long-term health
      status and clinical outcomes among patients with multivessel or left main CAD treated with
      PCI deemed ineligible for surgery.

      4. Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients
      with predicted STS survival (ASCERT risk model)

      5. Determine the justification for surgical ineligibility by cardiologists and cardiac
      surgeons among patients with severe multivessel or left main coronary artery disease (CAD).

      6. Describe the frequency and predictors of PCI versus medical management among surgically
      ineligible patients with severe multivessel or left main CAD.

      7. Describe the frequency and predictors of complete revascularization in this population.

      8. Describe the costs and costs per quality adjusted life year (QALY) gained of the strategy
      of management of multivessel or left main CAD with PCI versus medical therapy among
      surgically ineligible patients.
observational model: Cohort
time perspective: Prospective
measure: 30 day survival following high risk percutaneous coronary revascularization who are at high risk.
time frame: 30 days
description: Patients will be followed with phone calls at 30 days.
measure: 12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only.
time frame: 12 months
description: Patients will be called at 12 months time by the centralized follow up center.
arm group label: Guideline Directed Medical Therapy
description: Patients who have an initial treatment strategy of using guideline-directed medical therapy only.
arm group label: Percutaneous Coronary Intervention
description: Patients who will have a Percutaneous Coronary Intervention as the initial treatment strategy along with guideline directed medical therapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam C Salisbury, MD MSc
role: Principal Investigator
affiliation: Saint Luke's Health System
last name: David E Kandzari, MD
role: Principal Investigator
affiliation: Piedmont Heart and Vascular Institute
last name: James A Grantham, MD
role: Principal Investigator
affiliation: Saint Luke's Health System
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country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease