<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/NCT04451044</url>
  </required_header>
  <id_info>
    <org_study_id>190103</org_study_id>
    <nct_id>NCT04451044</nct_id>
  </id_info>
  <brief_title>Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting</brief_title>
  <acronym>DEFINE GPS</acronym>
  <official_title>Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Clinical &amp; Medical Affairs Global</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Clinical &amp; Medical Affairs Global</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-center, prospective, randomized controlled study comparing PCI guided by angiography&#xD;
      versus iFR Co-Registration using commercially available Philips pressure guidewires and the&#xD;
      SyncVision co-registration system, employing an adaptive design study for interim sample size&#xD;
      re-estimation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 17, 2021</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina</measure>
    <time_frame>30 days, 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause, cardiac and non-cardiac mortality</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for progressive or unstable ischemia</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis (definite, probable and definite/probable)</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angina-related Quality of Life</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
    <description>Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource utilization</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
    <description>The [US-based] cost of all health care resources associated with the index procedure and pre-specified event costs throughout the two-year follow up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness</measure>
    <time_frame>30 days, 1 year and 2 years</time_frame>
    <description>Cost per quality-adjusted life years gained</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3212</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>physiologically-guided arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>angiographically-guided arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care angiographically-guided PCI for determining the PCI strategy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Philips SyncVision system with Philips pressure wires</intervention_name>
    <description>Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy</description>
    <arm_group_label>physiologically-guided arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>standard of care angiographically-guided PCI</intervention_name>
    <description>Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy</description>
    <arm_group_label>angiographically-guided arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Adult men and women (local age of consent) who present with stable or unstable&#xD;
             angina, or NSTEMI.&#xD;
&#xD;
          -  2. Undergoing cardiac catheterization with planned PCI or possible ad hoc PCI&#xD;
&#xD;
          -  3. Following angiography, PCI is indicated in at least one coronary artery* on the&#xD;
             basis of one or more of the following:&#xD;
&#xD;
               1. Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac&#xD;
                  enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;&#xD;
&#xD;
               2. One or more angiographic stenoses present with ≥80% stenosis severity by visual&#xD;
                  estimation;&#xD;
&#xD;
               3. One or more angiographic stenoses present with ≥50% to &lt;80% stenosis severity by&#xD;
                  visual estimation and an abnormal non-invasive stress test in the distribution of&#xD;
                  the lesion(s) within the past 60 days;&#xD;
&#xD;
               4. One or more angiographic stenoses are present with ≥50% to &lt;80% stenosis severity&#xD;
                  by visual estimation and a spot iFR measure ≤0.89 or FFR≤0.80 for borderline&#xD;
                  iFR..&#xD;
&#xD;
          -  4 Subject is willing to comply with all scheduled visits and tests and has provided&#xD;
             informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. STEMI within 30 days&#xD;
&#xD;
          -  2. PCI within the prior 12 months, or any PCI planned after the study procedure (other&#xD;
             than planned staged procedures of randomized vessels which are allowed)&#xD;
&#xD;
          -  3. Prior CABG anytime&#xD;
&#xD;
          -  4. Silent ischemia only (i.e. no cardiac symptoms related to coronary artery disease)&#xD;
             within the prior 4 weeks&#xD;
&#xD;
          -  5. Documented prior iFR pullback performed in any coronary artery including during the&#xD;
             qualifying diagnostic angiogram&#xD;
&#xD;
          -  6. Any vessel with in-stent restenosis (ISR) requiring treatment&#xD;
&#xD;
          -  7. Cardiogenic shock defined as systolic blood pressure &lt;90 mmHg for &gt;20 minutes not&#xD;
             responding to fluid resuscitation, or need for inotropic, pressor, or device-based&#xD;
             hemodynamic support&#xD;
&#xD;
          -  8. Presence of unstable ventricular arrhythmias&#xD;
&#xD;
          -  9. Heart rate &gt; 110, including uncontrolled atrial fibrillation (AF)&#xD;
&#xD;
          -  10. Decompensated congestive heart failure (NYHA Class IV or Killip Class III or IV)&#xD;
&#xD;
          -  11. Chronic total occlusion (CTO) of a target vessel (exception: a CTO may be present&#xD;
             in a non-target vessel if it is supplying non-viable myocardium and there is no intent&#xD;
             to open the CTO during the index or later procedure)&#xD;
&#xD;
          -  12. Coronary anatomy not amenable to pressure wire manipulation due to extreme&#xD;
             tortuosity or complexity such that it is unlikely that a pressure wire could be passed&#xD;
             to the distal third of the three major epicardial coronary arteries&#xD;
&#xD;
          -  13. Any angiographic giant thrombus (i.e., thrombus length &gt; 3x RVD at lesion)&#xD;
&#xD;
          -  14. Any target vessel with &lt; TIMI III flow&#xD;
&#xD;
          -  15. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm except&#xD;
             for within the side branch of a bifurcation lesion&#xD;
&#xD;
          -  16. Any non-target lesion with a reference vessel diameter (RVD) greater than 2.00mm&#xD;
             that contains an ≥80% stenosis and is not intended for treatment with PCI (other than&#xD;
             a CTO supplying non-viable myocardium - see exclusion #11)&#xD;
&#xD;
          -  17. Known severe aortic or mitral valve stenosis/insufficiency&#xD;
&#xD;
          -  18. Known non-cardiovascular comorbidity resulting in lifespan &lt;24 months&#xD;
&#xD;
          -  19. Known left ventricular ejection fraction ≤30%&#xD;
&#xD;
          -  20. Estimated creatinine clearance (MDRD formula) &lt;30 mL/min/1.73m2 or on dialysis&#xD;
&#xD;
          -  21. Any cardiac or non-cardiac surgical procedure planned within 12 months after&#xD;
             enrollment, or any procedure planned within 6 months after enrollment that would&#xD;
             necessitate discontinuation of dual antiplatelet therapy&#xD;
&#xD;
          -  22. Known pregnancy or planning to become pregnant (women of child-bearing potential&#xD;
             must have a negative pregnancy test within 1 week of enrollment)&#xD;
&#xD;
          -  23. Participating in another investigational drug or device study that has not reached&#xD;
             its primary endpoint&#xD;
&#xD;
          -  24. Any condition such as dementia or substance abuse that may impair the patient's&#xD;
             ability to comply with all study procedures, including medication compliance and&#xD;
             follow-up visits&#xD;
&#xD;
          -  25. Patient is a member of a vulnerable population who, in the judgment of the&#xD;
             investigator, is unable to give Informed Consent for reasons of incapacity,&#xD;
             immaturity, adverse personal circumstances or lack of autonomy. This may include&#xD;
             individuals with mental disability, persons in nursing homes, children, impoverished&#xD;
             persons, persons in emergency situations, homeless persons, nomads, refugees, and&#xD;
             those permanently incapable of giving informed consent. Vulnerable populations also&#xD;
             include university students, subordinate hospital and laboratory personnel, employees&#xD;
             of the Sponsor, members of the armed forces, and persons kept in detention.&#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>Allen Jeremias, MD MSC FACC FSCAI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Francis Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregg W Stone, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pima Heart &amp; Vascular</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Arkansas Veterans Healthcare System (CAVHS)</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Heart and Vascular</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar 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>Memorial Healthcare</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Cardiovascular Innovations and Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Straub Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Community Hospital</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Healthcare System</name>
      <address>
        <city>Munster</city>
        <state>Indiana</state>
        <zip>46321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mass General</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Health Services</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gates Vascular Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia 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>St. Francis Hospital</name>
      <address>
        <city>Roslyn</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NC Heart and Vascular Research, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summa Health System</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44304</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>Bryn Mawr Hospital</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Central Heart</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White, The Heart Hospital Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gosford Hospital</name>
      <address>
        <city>Gosford</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>Saint Leonards</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Macquarie Private Hospital</name>
      <address>
        <city>Gateshead</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademisches Lehrkrankenhaus Feldkirch</name>
      <address>
        <city>Feldkirch</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imeldaziekenhuis Bonheiden</name>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Columbian Hospital</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Osler Health-Brampton Civic Hospital</name>
      <address>
        <city>Brampton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lille, Institut Coeur Poumon</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes Caremeau</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum im Friedrichshain</name>
      <address>
        <city>Berlin</city>
        <zip>10249</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erlangen University Hospital</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Essen</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitsklinik Freiburg</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shamir Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Querétaro</name>
      <address>
        <city>Querétaro</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Med Ctr</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Prof. Doutour Fernando Foneseca</name>
      <address>
        <city>Amadora</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía</name>
      <address>
        <city>Córdoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Leon</name>
      <address>
        <city>León</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecillas</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skane University Hospital</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>S016 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</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>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</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>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451044
org study id: 190103
nct id: NCT04451044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Multi-center, prospective, randomized controlled study comparing PCI guided by angiography
      versus iFR Co-Registration using commercially available Philips pressure guidewires and the
      SyncVision co-registration system, employing an adaptive design study for interim sample size
      re-estimation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years
time frame: 2 years
measure: Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina
time frame: 30 days, 1 year
measure: All-cause, cardiac and non-cardiac mortality
time frame: 30 days, 1 year and 2 years
measure: All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI
time frame: 30 days, 1 year and 2 years
measure: Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR
time frame: 30 days, 1 year and 2 years
measure: Hospitalization for progressive or unstable ischemia
time frame: 30 days, 1 year and 2 years
measure: Stent thrombosis (definite, probable and definite/probable)
time frame: 30 days, 1 year and 2 years
measure: Angina-related Quality of Life
time frame: 30 days, 1 year and 2 years
description: Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score
measure: Resource utilization
time frame: 30 days, 1 year and 2 years
description: The [US-based] cost of all health care resources associated with the index procedure and pre-specified event costs throughout the two-year follow up period
measure: Cost effectiveness
time frame: 30 days, 1 year and 2 years
description: Cost per quality-adjusted life years gained
arm group label: physiologically-guided arm
arm group type: Experimental
description: Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
arm group label: angiographically-guided arm
arm group type: Active Comparator
description: Standard of care angiographically-guided PCI for determining the PCI strategy
intervention type: Device
intervention name: Philips SyncVision system with Philips pressure wires
description: Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
arm group label: physiologically-guided arm
intervention type: Procedure
intervention name: standard of care angiographically-guided PCI
description: Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy
arm group label: angiographically-guided arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Allen Jeremias, MD MSC FACC FSCAI
role: Principal Investigator
affiliation: Saint Francis Memorial Hospital
last name: Gregg W Stone, MD
role: Study Chair
affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: France
country: Germany
country: Israel
country: Mexico
country: Netherlands
country: Portugal
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Heart Diseases
sharing ipd: No