<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/NCT04443530</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2020-07</org_study_id>
    <nct_id>NCT04443530</nct_id>
  </id_info>
  <brief_title>Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice</brief_title>
  <acronym>IRIS Tansei</acronym>
  <official_title>Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duk-Woo Park, MD</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 is to evaluate the effectiveness and safety of Ultimaster Tansei stent in the&#xD;
      &quot;real-world&quot; daily practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 17, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">September 17, 2024</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>1 year</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 that 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 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 myocardial infarction</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The composite event rate of death or myocardial infarction</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of target-vessel revascularization</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The event rate of target-lesion revascularization</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 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>3 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>Coronary artery stenosis</arm_group_label>
    <description>Patients with coronary artery disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ultimaster™ Tansei™ stents</intervention_name>
    <description>Patients receiving Ultimaster™ Tansei™ stents</description>
    <arm_group_label>Coronary artery stenosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Ultimaster™ Tansei™ 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 Ultimaster™ Tansei™ 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 drug-eluting stents (DESs)&#xD;
&#xD;
          2. Terminal illness with life-expectancy ≤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, RN</last_name>
    <phone>82230104728</phone>
    <email>cvcrc5@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gangwon National Univ. Hospital</name>
      <address>
        <city>Chuncheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bong-ki Lee, MD</last_name>
    </contact>
    <investigator>
      <last_name>Bong-ki Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin-bae Lee, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jin-bae Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyuck-joon Yoon, MD</last_name>
    </contact>
    <investigator>
      <last_name>Hyuck-joon Yoon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Daejeon ST. Mary's Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Man-won Park, MD</last_name>
    </contact>
    <investigator>
      <last_name>Man-won Park, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gangneung Asan Hospital</name>
      <address>
        <city>Gangneung</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang-yong Yoo, MD</last_name>
    </contact>
    <investigator>
      <last_name>Sang-yong Yoo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kwangju Christian Hospital</name>
      <address>
        <city>Kwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seung-uk Lee, MD</last_name>
    </contact>
    <investigator>
      <last_name>Seung-uk Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Han-cheol Lee, MD</last_name>
    </contact>
    <investigator>
      <last_name>Han-cheol Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Duk-woo Park, MD</last_name>
      <email>dwpark@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Duk-woo Park, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kangdong Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Won-woo Seo, MD</last_name>
    </contact>
    <investigator>
      <last_name>Won-woo Seo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Catholic Univ. of Korea Eunpyeong St. Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>St.Carollo Hospital</name>
      <address>
        <city>Suncheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jang-hyun Cho, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jang-hyun Cho, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>February 5, 2023</last_update_submitted>
  <last_update_submitted_qc>February 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 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>Duk-Woo Park, MD</investigator_full_name>
    <investigator_title>Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine</investigator_title>
  </responsible_party>
  <keyword>Tansei</keyword>
  <keyword>Ultimaster</keyword>
  <keyword>Ultimaster Tansei</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery 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>


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/NCT04443530
org study id: AMCCV2020-07
nct id: NCT04443530
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent in the
      "real-world" daily 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: 1 year
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 that is considered to have occurred if any one of several different events is observed.
measure: The event rate of all death
time frame: 5 years
measure: The event rate of cardiac death
time frame: 5 years
measure: The event rate of myocardial infarction
time frame: 5 years
measure: The composite event rate of death or myocardial infarction
time frame: 5 years
measure: The event rate of target-vessel revascularization
time frame: 5 years
measure: The event rate of target-lesion revascularization
time frame: 5 years
measure: The event rate of stent thrombosis
time frame: 5 years
description: According to Academic Research Consortium(ARC) criteria
measure: The event rate of stroke
time frame: 5 years
measure: The event rate of procedural success
time frame: 3 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: Coronary artery stenosis
description: Patients with coronary artery disease
intervention type: Drug
intervention name: Ultimaster™ Tansei™ stents
description: Patients receiving Ultimaster™ Tansei™ stents
arm group label: Coronary artery stenosis
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, RN
phone: 82230104728
email: cvcrc5@amc.seoul.kr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Duk-Woo Park, MD
investigator title: Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine
mesh term: Coronary Artery Disease
sharing ipd: Undecided