xml: <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/NCT05981911</url>
    </required_header>
    <id_info>
      <org_study_id>AMCCV2023-04</org_study_id>
      <nct_id>NCT05981911</nct_id>
    </id_info>
    <brief_title>Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice</brief_title>
    <acronym>IRIS Skypoint</acronym>
    <official_title>a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease</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>
        The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint&#xD;
        stents in comparison to other drug-eluting stents (DES) in real-world practice.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)</measure>
      <time_frame>12 months</time_frame>
      <description>the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure.&#xD;
  A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the event rate of all cause death</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the event rate of cardiac death</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the event rate of nonfatal myocardial infarction</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the composite event rate of death, or nonfatal myocardial infarction (MI)</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the event rate of Target- Vessel Revascularization (TVR)</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the event rate of Target- lesion Revascularization (TLR)</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the event rate of stent thrombosis</measure>
      <time_frame>5 years</time_frame>
      <description>according to an Academic Research Consortium (ARC) criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the event rate of stroke</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the event rate of Procedural success</measure>
      <time_frame>7 days</time_frame>
      <description>(defined as achievement of a final diameter stenosis of &lt;30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>XIENCE Skypoint™ stent</arm_group_label>
      <description>Patients receiving Xience-Skypoint™ stents</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>XIENCE Skypoint™ stent</intervention_name>
      <description>Percutaneous coronary intervention with Xience-Skypoint™ stent</description>
      <arm_group_label>XIENCE Skypoint™ stent</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients receiving Xience-Skypoint™ stents.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients ≥ 19 years old&#xD;
  &#xD;
            2. Patients receiving Xience-Skypoint™ stents.&#xD;
  &#xD;
            3. 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/Ethics Committee of the respective clinical site.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a mixture of other DESs&#xD;
  &#xD;
            2. Terminal illness with life expectancy &lt;1 year&#xD;
  &#xD;
            3. Patients with cardiogenic shock&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jung-hee Ham, Project manager</last_name>
      <phone>82230104728</phone>
      <email>cvcrc5@amc.seoul.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Asan Medical 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>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</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, Department of Cardiology, University of Ulsan College of Medicine</investigator_title>
    </responsible_party>
    <keyword>drug eluting stent</keyword>
    <keyword>Percutaneous Coronary Intervention</keyword>
    <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>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981911
  org study id: AMCCV2023-04
  nct id: NCT05981911
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint
        stents in comparison to other drug-eluting stents (DES) in real-world practice.
  observational model: Cohort
  time perspective: Prospective
  measure: the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
  time frame: 12 months
  description: the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure.
  A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
  measure: the event rate of all cause death
  time frame: 5 years
  measure: the event rate of cardiac death
  time frame: 5 years
  measure: the event rate of nonfatal myocardial infarction
  time frame: 5 years
  measure: the composite event rate of death, or nonfatal myocardial infarction (MI)
  time frame: 5 years
  measure: the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)
  time frame: 5 years
  measure: the event rate of Target- Vessel Revascularization (TVR)
  time frame: 5 years
  measure: the event rate of Target- lesion Revascularization (TLR)
  time frame: 5 years
  measure: the event rate of stent thrombosis
  time frame: 5 years
  description: according to an Academic Research Consortium (ARC) criteria
  measure: the event rate of stroke
  time frame: 5 years
  measure: the event rate of Procedural success
  time frame: 7 days
  description: (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.
  arm group label: XIENCE Skypoint™ stent
  description: Patients receiving Xience-Skypoint™ stents
  intervention type: Device
  intervention name: XIENCE Skypoint™ stent
  description: Percutaneous coronary intervention with Xience-Skypoint™ stent
  arm group label: XIENCE Skypoint™ stent
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jung-hee Ham, Project manager
  phone: 82230104728
  email: cvcrc5@amc.seoul.kr
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: Asan Medical Center
  investigator full name: Seung-Jung Park
  investigator title: Professor, Department of Cardiology, University of Ulsan College of Medicine
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: Undecided