<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/NCT02978456</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2016-24</org_study_id>
    <nct_id>NCT02978456</nct_id>
  </id_info>
  <brief_title>Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation</brief_title>
  <acronym>GUIDE DES</acronym>
  <official_title>Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation: GUIDE-DES Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHEOL WHAN LEE, M.D., Ph.D</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biotronik SE &amp; Co. KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare clinical outcomes between quantitative coronary&#xD;
      angiography -guided and Intravascular ultrasound -guided strategy in patients with&#xD;
      significant coronary artery disease undergoing sirolimus-eluting Orsiro/Orsiro mission stent&#xD;
      implantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 23, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Target lesion failure</measure>
    <time_frame>12 months</time_frame>
    <description>the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>24 hours</time_frame>
    <description>Achievement of final stent residual stenosis of less than 30% by QCA with successful deployment of at least one stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (24 hour after an index procedure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death (cardiac, vascular, non-cardiovascular)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis (definite/probable)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any revascularization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic analysis</measure>
    <time_frame>12 months</time_frame>
    <description>cost-effectiveness of QCA- versus IVUS-guided DES implantation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1528</enrollment>
  <condition>Coronary Disease</condition>
  <condition>Coronary Stenoses</condition>
  <arm_group>
    <arm_group_label>quantitative coronary angiography guided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravascular ultrasound guided</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent</intervention_name>
    <description>In the quantitative coronary angiography-guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is chosen to cover the entire length of the culprit lesions according to quantitative coronary angiography measurements. Selection of the sirolimus-eluting Orsiro/Orsiro mission stent size should be guided by both quantitative coronary angiography measurement and visual estimate, and is recommended to be based on distal reference vessel diameter by quantitative coronary angiography (distal reference vessel diameter by quantitative coronary angiography plus ~10% of distal reference vessel diameter).</description>
    <arm_group_label>quantitative coronary angiography guided</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent</intervention_name>
    <description>In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements.</description>
    <arm_group_label>Intravascular ultrasound guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men or women at least 19years of age&#xD;
&#xD;
          2. Typical chest pain or objective evidence of myocardial ischemia suitable for elective&#xD;
             PCI&#xD;
&#xD;
          3. Significant coronary artery lesions suitable for sirolimus-eluting Orsiro/Orsiro&#xD;
             mission stent implantation&#xD;
&#xD;
          4. The patient or guardian agrees to the study protocol and the schedule of clinical&#xD;
             follow-up, and provides informed, written consent, as approved by the appropriate&#xD;
             Institutional Review Board/Ethical Committee of the respective clinical site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Angiographic exclusion criteria: any of the followings 1)Bypass graft lesions&#xD;
             2)Impaired delivery of IVUS is expected:&#xD;
&#xD;
               -  Extreme angulation (≥90°) proximal to or within the target lesion.&#xD;
&#xD;
               -  Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.&#xD;
&#xD;
               -  Heavy calcification proximal to or within the target lesion.&#xD;
&#xD;
          2. Previous percutaneous coronary intervention within 6 months before the index procedure&#xD;
&#xD;
          3. Previous BVS (bioresorbable vascular scaffold) implantation&#xD;
&#xD;
          4. Left ventricular ejection fraction (LVEF) &lt; 30%&#xD;
&#xD;
          5. Hypersensitivity or contraindication to device material and its degradants and cobalt,&#xD;
             chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be&#xD;
             adequately pre-medicated.&#xD;
&#xD;
          6. Persistent thrombocytopenia (platelet count &lt;100,000/µl)&#xD;
&#xD;
          7. Any history of hemorrhagic stroke or intracranial hemorrhage, Transient ischemic&#xD;
             attack or ischemic stroke within the past 6 months&#xD;
&#xD;
          8. A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or&#xD;
             ticagrelor)&#xD;
&#xD;
          9. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP&#xD;
             antagonist is planned within 12 months after the procedure.&#xD;
&#xD;
         10. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in&#xD;
             the past 3 years or current treatment for the active cancer.&#xD;
&#xD;
         11. Any clinically significant abnormality identified at the screening visit, physical&#xD;
             examination, laboratory tests, or electrocardiogram which, in the judgment of the&#xD;
             Investigator, would preclude safe completion of the study.&#xD;
&#xD;
         12. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation&#xD;
             (ALT or AST &gt; 3 times upper limit of normal).&#xD;
&#xD;
         13. Life expectancy &lt; 1 years for any non-cardiac or cardiac causes&#xD;
&#xD;
         14. Unwillingness or inability to comply with the procedures described in this protocol.&#xD;
&#xD;
         15. Patient's pregnant or breast-feeding or child-bearing potential.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Anam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Medical Center</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Health Insurance Service Ilsan Hospital</name>
      <address>
        <city>Ilsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Christian Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic Univ. of Korea Seoul St. Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>CHEOL WHAN LEE, M.D., Ph.D</investigator_full_name>
    <investigator_title>professor, Division of Cardiology, Department of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>IVUS guided PCI</keyword>
  <keyword>QCA guided PCI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Temsirolimus</mesh_term>
    <mesh_term>MTOR Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02978456
org study id: AMCCV2016-24
nct id: NCT02978456
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare clinical outcomes between quantitative coronary
      angiography -guided and Intravascular ultrasound -guided strategy in patients with
      significant coronary artery disease undergoing sirolimus-eluting Orsiro/Orsiro mission stent
      implantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Target lesion failure
time frame: 12 months
description: the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.
measure: Procedural success
time frame: 24 hours
description: Achievement of final stent residual stenosis of less than 30% by QCA with successful deployment of at least one stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (24 hour after an index procedure).
measure: Death (cardiac, vascular, non-cardiovascular)
time frame: 12 months
measure: Myocardial infarction
time frame: 12 months
measure: Stent thrombosis (definite/probable)
time frame: 12 months
measure: Stroke
time frame: 12 months
measure: Target lesion revascularization
time frame: 12 months
measure: Any revascularization
time frame: 12 months
measure: Economic analysis
time frame: 12 months
description: cost-effectiveness of QCA- versus IVUS-guided DES implantation
arm group label: quantitative coronary angiography guided
arm group type: Experimental
arm group label: Intravascular ultrasound guided
arm group type: Active Comparator
intervention type: Device
intervention name: quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
description: In the quantitative coronary angiography-guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is chosen to cover the entire length of the culprit lesions according to quantitative coronary angiography measurements. Selection of the sirolimus-eluting Orsiro/Orsiro mission stent size should be guided by both quantitative coronary angiography measurement and visual estimate, and is recommended to be based on distal reference vessel diameter by quantitative coronary angiography (distal reference vessel diameter by quantitative coronary angiography plus ~10% of distal reference vessel diameter).
arm group label: quantitative coronary angiography guided
intervention type: Device
intervention name: intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent
description: In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements.
arm group label: Intravascular ultrasound guided
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: CHEOL WHAN LEE, M.D., Ph.D
investigator title: professor, Division of Cardiology, Department of Internal Medicine
mesh term: Coronary Disease
mesh term: Coronary Stenosis
mesh term: Sirolimus
mesh term: Temsirolimus
mesh term: MTOR Inhibitors
sharing ipd: Undecided