<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/NCT04475978</url>
  </required_header>
  <id_info>
    <org_study_id>2020YLK5</org_study_id>
    <nct_id>NCT04475978</nct_id>
  </id_info>
  <brief_title>Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial</brief_title>
  <official_title>Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiamen Cardiovascular Hospital, Xiamen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiamen Cardiovascular Hospital, Xiamen University</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>
      Objectives: The present study aimed to investigate the difference in late luminal loss (LLL)&#xD;
      at 9-month after drug-coated balloon (DCB) treatment with intravascular ultrasound (IVUS)&#xD;
      versus angiography for ST-segment elevated myocardial infarction （STEMI）patients.&#xD;
&#xD;
      Background: In primary percutaneous coronary intervention for STEMI, DCB angioplasty has&#xD;
      proved to be a safe and feasible strategy. Compare with angiography guidance, IVUS-guided PCI&#xD;
      significantly improve clinical outcome. With IVUS guidance, STEMI patients undergo DCB&#xD;
      angioplasty might have be beneficial results.&#xD;
&#xD;
      Methods: A total of 208 STEMI patients who required DCB treatment were randomly assigned&#xD;
      either an IVUS guidance and angiography guidance group. The primary endpoint was late luminal&#xD;
      loss at 9-month. Stent thrombosis (ST) was the safety endpoint.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">March 30, 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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>late lumen loss（LLL）</measure>
    <time_frame>At 9 months follow-up</time_frame>
    <description>late lumen loss（LLL）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>target lesion failure (TLF)</measure>
    <time_frame>At 1-year follow-up</time_frame>
    <description>the composite of car- diac death, target-vessel MI (TVMI), or clinically driven TLR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">208</enrollment>
  <condition>STEMI</condition>
  <arm_group>
    <arm_group_label>IVUS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Angio group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IVUS-guide DCB PTCA</intervention_name>
    <description>IVUS-guide DCB PTCA</description>
    <arm_group_label>IVUS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Angio-guide DCB PTCA</intervention_name>
    <description>Angio-guide DCB PTCA</description>
    <arm_group_label>Angio group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction eligible for PPCI:&#xD;
&#xD;
               1. &gt;20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous&#xD;
                  leads, a new left bundle branch block or a true posterior myocardial infarction&#xD;
                  (confirmed by ECG or echocardiography) .&#xD;
&#xD;
               2. Reperfusion is expected to be feasible within 12 h after onset of complaints.&#xD;
&#xD;
          -  Infarct related artery eligible for PPCI and:&#xD;
&#xD;
               1. De novo lesion in a native coronary artery&#xD;
&#xD;
               2. Reference-vessel diameter 2.5 mm and 4 mm&#xD;
&#xD;
               3. Diameter stenosis of &gt;50% (by visual assessment) after thrombus aspiration and&#xD;
                  pre-dilatation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Age &lt;18 yr and &gt;85 yr&#xD;
&#xD;
          -  History of myocardial infarction&#xD;
&#xD;
          -  lesion length &gt; 30m&#xD;
&#xD;
          -  Left Main lesion&#xD;
&#xD;
          -  Ostial lesion&#xD;
&#xD;
          -  None-target vessel need to treat with PCI&#xD;
&#xD;
          -  Severe calcification&#xD;
&#xD;
          -  Severe tortuosity&#xD;
&#xD;
          -  Severe angulation&#xD;
&#xD;
          -  Cardiogenic shock before pre-dilation or any serious cases can not perform IVUS&#xD;
&#xD;
          -  Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin,&#xD;
             prasugrel and/or ticagrelor&#xD;
&#xD;
          -  Participation in another clinical study, interfering with this protocol Uncertain&#xD;
&#xD;
          -  Known intracranial disease (mass, aneurysm, AVM, haemorrhagic CVA, ischemic CVA/TIA &lt;6&#xD;
             months before inclusion or ischemic CVA with permanent neurological deficit)&#xD;
             Gastrointestinal/urinary tract&#xD;
&#xD;
          -  bleeding &lt;2 months before inclusion Refusal to receive blood transfusion&#xD;
&#xD;
          -  Planned major surgery within 6 weeks&#xD;
&#xD;
          -  Stent implantation &lt;1 week before inclusion&#xD;
&#xD;
          -  Expected mortality from any cause within the next 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yulin Zhou, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trial Center of Xiamen Cardiovascular Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiang Chen, MD</last_name>
    <phone>18033997788</phone>
    <email>Seanchenx@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiamen Cardiovascular Hospital Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bin Wang, Ph.D</last_name>
      <phone>+8613400664305</phone>
      <email>mocw361@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>October 29, 2022</last_update_submitted>
  <last_update_submitted_qc>October 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>drug-coated balloon</keyword>
  <keyword>IVUS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT04475978
org study id: 2020YLK5
nct id: NCT04475978
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives: The present study aimed to investigate the difference in late luminal loss (LLL)
      at 9-month after drug-coated balloon (DCB) treatment with intravascular ultrasound (IVUS)
      versus angiography for ST-segment elevated myocardial infarction （STEMI）patients.

      Background: In primary percutaneous coronary intervention for STEMI, DCB angioplasty has
      proved to be a safe and feasible strategy. Compare with angiography guidance, IVUS-guided PCI
      significantly improve clinical outcome. With IVUS guidance, STEMI patients undergo DCB
      angioplasty might have be beneficial results.

      Methods: A total of 208 STEMI patients who required DCB treatment were randomly assigned
      either an IVUS guidance and angiography guidance group. The primary endpoint was late luminal
      loss at 9-month. Stent thrombosis (ST) was the safety endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: late lumen loss（LLL）
time frame: At 9 months follow-up
description: late lumen loss（LLL）
measure: target lesion failure (TLF)
time frame: At 1-year follow-up
description: the composite of car- diac death, target-vessel MI (TVMI), or clinically driven TLR
arm group label: IVUS group
arm group type: Experimental
arm group label: Angio group
arm group type: Placebo Comparator
intervention type: Device
intervention name: IVUS-guide DCB PTCA
description: IVUS-guide DCB PTCA
arm group label: IVUS group
intervention type: Device
intervention name: Angio-guide DCB PTCA
description: Angio-guide DCB PTCA
arm group label: Angio group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yulin Zhou, Ph.D
role: Principal Investigator
affiliation: Clinical Trial Center of Xiamen Cardiovascular Hospital
last name: Xiang Chen, MD
phone: 18033997788
email: Seanchenx@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: ST Elevation Myocardial Infarction