<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/NCT03788369</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2018-12</org_study_id>
    <nct_id>NCT03788369</nct_id>
  </id_info>
  <brief_title>Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization</brief_title>
  <acronym>HCR registry</acronym>
  <official_title>Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization, a Non-randomized, Prospective, Open-label Registry in Real-world Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seung-Jung Park</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CardioVascular Research Foundation, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in&#xD;
      real-world practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 5, 2019</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">June 2030</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.</measure>
    <time_frame>5 years</time_frame>
    <description>Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All death</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a composite event of all death or myocardial infarction</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a composite event of cardiac death or myocardial infarction</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TVR(Target Vessel Revascularization)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TLR(Target Lesion Revascularization)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>5 years</time_frame>
    <description>by an Academic Research Consortium (ARC) category</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular event</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>5 days</time_frame>
    <description>Procedural success is defined as &lt; 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Percutaneous Coronary Revascularization</condition>
  <condition>Coronary Stenosis</condition>
  <condition>Coronary Artery Disease Progression</condition>
  <condition>Coronary Artery Bypass Grafting</condition>
  <arm_group>
    <arm_group_label>Multivessel coronary artery disease</arm_group_label>
    <description>must include left anterior descending artery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hybrid Coronary Revascularization</intervention_name>
    <description>Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.</description>
    <arm_group_label>Multivessel coronary artery disease</arm_group_label>
    <other_name>HCR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with hybrid coronary revascularization due to multivessel coronary artery&#xD;
        disease(must include left anterior descending artery)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20 and more&#xD;
&#xD;
          -  Hybrid coronary revascularization due to multivessel coronary artery disease(must&#xD;
             include left anterior descending artery)&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous CABG(coronary artery bypass graft)&#xD;
&#xD;
          -  Life expectancy ≤1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Do-yoon Kang, MD</last_name>
    <phone>82-2-3010-1745</phone>
    <email>kdy1218@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seung-jung Park, MD</last_name>
      <email>sjpark@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Seung-jung Park, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>June 30, 2022</last_update_submitted>
  <last_update_submitted_qc>June 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Seung-Jung Park</investigator_full_name>
    <investigator_title>Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</investigator_title>
  </responsible_party>
  <keyword>Hybrid coronary revascularization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_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/NCT03788369
org study id: AMCCV2018-12
nct id: NCT03788369
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in
      real-world practice.
observational model: Cohort
time perspective: Prospective
measure: a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.
time frame: 5 years
description: Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.
measure: All death
time frame: 5 years
measure: Cardiac death
time frame: 5 years
measure: Myocardial infarction
time frame: 5 years
measure: a composite event of all death or myocardial infarction
time frame: 5 years
measure: a composite event of cardiac death or myocardial infarction
time frame: 5 years
measure: TVR(Target Vessel Revascularization)
time frame: 5 years
measure: TLR(Target Lesion Revascularization)
time frame: 5 years
measure: Stent thrombosis
time frame: 5 years
description: by an Academic Research Consortium (ARC) category
measure: Cerebrovascular event
time frame: 5 years
measure: Procedural success
time frame: 5 days
description: Procedural success is defined as < 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization.
arm group label: Multivessel coronary artery disease
description: must include left anterior descending artery
intervention type: Procedure
intervention name: Hybrid Coronary Revascularization
description: Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.
arm group label: Multivessel coronary artery disease
other name: HCR
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Do-yoon Kang, MD
phone: 82-2-3010-1745
email: kdy1218@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Seung-Jung Park
investigator title: Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
mesh term: Coronary Artery Disease
mesh term: Coronary Stenosis
mesh term: Disease Progression
sharing ipd: Undecided