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/NCT06002932</url>
    </required_header>
    <id_info>
      <org_study_id>XC22EIDI0051</org_study_id>
      <nct_id>NCT06002932</nct_id>
    </id_info>
    <brief_title>Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.</brief_title>
    <acronym>PROVISIONDEB</acronym>
    <official_title>Comparison of PROVISIONal 1-stent Strategy With Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients With Non-LM Coronary True-Bifurcation Lesions.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saint Vincent's Hospital, Korea</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saint Vincent's Hospital, Korea</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 Purpose of the Clinical Study] The purpose of this randomized comparison study is to&#xD;
        compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients&#xD;
        with non-LM coronary true-bifurcation lesions.&#xD;
  &#xD;
        [Hypothesis] In this study, the researchers intend to verify the hypothesis that the 1-stent&#xD;
        strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of&#xD;
        target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Provisional 1-stent plus DEB strategy As a principal, the treatment regime will be&#xD;
             composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a&#xD;
             branch vessel. The order of the treatments done to the main vessel and the branch vessel&#xD;
             shall be at the discretion of the treatment provider. Also, at the discretion of the&#xD;
             treatment provider, a bail-out stenting can still be performed, depending on the&#xD;
             condition of the branch vessel following a drug-eluting balloon treatment. However,&#xD;
             bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary&#xD;
             artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or&#xD;
             significant residual stenosis.&#xD;
  &#xD;
          2. Planned 2-stent strategy As per the conventional treatment process, this strategy treats&#xD;
             both the main vessel and the branch vessel with stents. The decision among Crush&#xD;
             (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the&#xD;
             treatment provider.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2028</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Intervention</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>target lesion failure the number of events</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">750</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Ischemic Heart Disease</condition>
    <arm_group>
      <arm_group_label>Conventional arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PROVISION-DEB arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Procedure: planed 2-stent strategy</intervention_name>
      <description>Procedure: planed 2-stent strategy</description>
      <arm_group_label>Conventional arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Procedure: provisional 1-stent plus DEB strategy</intervention_name>
      <description>Procedure: provisional 1-stent plus DEB strategy</description>
      <arm_group_label>PROVISION-DEB arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          ① 19+ years old&#xD;
  &#xD;
          ② Patients with the following lesions and clinical factors. 2-1. The lesion factor:&#xD;
          Visually confirmed diameter of the 2.25-2.75 mm in branched vessels, where the main blood&#xD;
          vessel's diameter is at least 2.5 mm; the lesion at the branched vessels is of a Medina&#xD;
          classification (1,1,1), (1,0,1), or (0,1,1), with a true bifurcation; a de novo lesion.&#xD;
  &#xD;
          2-2 Clinical factors: Stable angina pectoris, unstable angina pectoris, or myocardial&#xD;
          infarction with an elevated non-ST segment, all at least 24 hours after their last&#xD;
          treatment.&#xD;
  &#xD;
          ③ Patients who understood the definitions of the test group and the control group and the&#xD;
          risks involved in the treatment, and with voluntary, informed consent to participate in the&#xD;
          study, as provided either by the patient or their legal representatives.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with myocardial infarction involving an elevated ST segment, or patients with&#xD;
               an LM coronary true-bifurcation lesion.&#xD;
  &#xD;
                 -  Patients who are ruled out by the treatment provider because the 2-stent strategy&#xD;
                    was deemed unsuitable to the patient due to a clinical condition.&#xD;
  &#xD;
                      -  A patient with aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)&#xD;
                         contraindications.&#xD;
  &#xD;
                           -  A patient who experienced psychogenic shock at the time of admission,&#xD;
                              or showed severe left ventricle insufficiency (where the left ventricle&#xD;
                              ejection fraction is less than 30%.)&#xD;
  &#xD;
                                -  A patient who requires prolonged anti-coagulative treatment&#xD;
                                   (warfarin or a new oral anti-coagulant [NOAC])&#xD;
  &#xD;
                                     -  A patient who is currently hemorrhagic, or has a high risk of&#xD;
                                        major hemorrhage (active peptic ulcer, GI lesions with high&#xD;
                                        hemorrhagic risks, malicious tumors with a high risk of&#xD;
                                        hemorrhage) ⑦ A patient with a history of intra-cerebral&#xD;
                                        hemorrhage or intra-cerebral aneurysm.&#xD;
  &#xD;
                                          -  A patient for whom surgery that requires antiplatelet&#xD;
                                             treatment intervention is scheduled within the next six&#xD;
                                             months.&#xD;
  &#xD;
                                             ⑨ A patient with severe hepatic diseases (abdominal&#xD;
                                             effusion) Platelet count at less than 80,000 cells/mm3&#xD;
                                             Hgb count at less than 10 g/dL&#xD;
  &#xD;
                                             ⑩ A patient who appears to be at risk of bradycardia (a&#xD;
                                             patient with an insufficiency of the said function, or a&#xD;
                                             patient without a permanent pacemaker despite a grade 2&#xD;
                                             or higher atrioventricular block).&#xD;
  &#xD;
                                             ⑪ A patient who tested positive in a pregnancy test, or&#xD;
                                             is currently breastfeeding&#xD;
  &#xD;
                                             ⑫ A patient with less than one year of remaining life&#xD;
                                             expectancy due to comorbidity (based on the medical&#xD;
                                             judgment of the investigator).&#xD;
  &#xD;
                                             ⑬ A patient who is already participating in another&#xD;
                                             randomized clinical study for other medicines or medical&#xD;
                                             devices, where the primary end point has not been&#xD;
                                             reached.&#xD;
  &#xD;
                                             ⑭ A patient who did not sign her informed consent form,&#xD;
                                             or could not be traced in the long-term.&#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_official>
      <last_name>Sung-Ho Her, MD. PhD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>St Vincent's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sung-Ho Her, MD. PhD.</last_name>
      <phone>+82312598397</phone>
      <email>hhhsungho@naver.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kyusup Lee, MD. PhD.</last_name>
      <phone>+821090590389</phone>
      <email>ajobi7121@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>St. Vincent's Hospital , the Catholic University</name>
        <address>
          <city>Suwon</city>
          <state>Gyeonggi-do</state>
          <zip>16247</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sung-Ho Her, MD. PhD.</last_name>
        <phone>+82312598397</phone>
        <email>hhhsungho@naver.com</email>
      </contact>
      <contact_backup>
        <last_name>Kyusup Lee, MD. PhD.</last_name>
        <phone>+821090590389</phone>
        <email>ajobi7121@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>coronary artery disease</keyword>
    <keyword>percutaneous coronary intervention</keyword>
    <keyword>coronary bifurcation lesion</keyword>
    <keyword>strategy</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>
      <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>
  
  
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/NCT06002932
  org study id: XC22EIDI0051
  nct id: NCT06002932
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  [The Purpose of the Clinical Study] The purpose of this randomized comparison study is to
        compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients
        with non-LM coronary true-bifurcation lesions.
  
        [Hypothesis] In this study, the researchers intend to verify the hypothesis that the 1-stent
        strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of
        target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).
  1. Provisional 1-stent plus DEB strategy As a principal, the treatment regime will be
             composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a
             branch vessel. The order of the treatments done to the main vessel and the branch vessel
             shall be at the discretion of the treatment provider. Also, at the discretion of the
             treatment provider, a bail-out stenting can still be performed, depending on the
             condition of the branch vessel following a drug-eluting balloon treatment. However,
             bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary
             artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or
             significant residual stenosis.
  
          2. Planned 2-stent strategy As per the conventional treatment process, this strategy treats
             both the main vessel and the branch vessel with stents. The decision among Crush
             (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the
             treatment provider.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Intervention
  primary purpose: Treatment
  masking: None (Open Label)
  measure: target lesion failure the number of events
  time frame: 12 months after randomization
  description: composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)
  arm group label: Conventional arm
  arm group type: Active Comparator
  description: As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.
  arm group label: PROVISION-DEB arm
  arm group type: Experimental
  description: As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis.
  intervention type: Procedure
  intervention name: Procedure: planed 2-stent strategy
  description: Procedure: planed 2-stent strategy
  arm group label: Conventional arm
  intervention type: Procedure
  intervention name: Procedure: provisional 1-stent plus DEB strategy
  description: Procedure: provisional 1-stent plus DEB strategy
  arm group label: PROVISION-DEB arm
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sung-Ho Her, MD. PhD.
  role: Principal Investigator
  affiliation: St Vincent's Hospital
  last name: Sung-Ho Her, MD. PhD.
  phone: +82312598397
  email: hhhsungho@naver.com
  last name: Kyusup Lee, MD. PhD.
  phone: +821090590389
  email: ajobi7121@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  mesh term: Heart Diseases
  sharing ipd: No