<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/NCT03282773</url>
  </required_header>
  <id_info>
    <org_study_id>B2017-104</org_study_id>
    <nct_id>NCT03282773</nct_id>
  </id_info>
  <brief_title>Optimal Strategy of Primary PCI for Left Main Coronary Artery Occlusion Induced AMI</brief_title>
  <acronym>OPTIMAL</acronym>
  <official_title>Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Due to Unprotected Left Main Coronary Artery Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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 will compare clinical outcomes of immediate stent implantation with deferred stent&#xD;
      implantation(4-10days after primary angiography) for patients presented with acute myocardial&#xD;
      infarction due to left main coronary artery occlusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary percutaneous coronary intervention for patients presented with acute myocardial&#xD;
      infarction caused by left main coronary artery occlusion is associated with significantly&#xD;
      higher mortality and risks of major cardiac adverse events. Deferred stent implantation may&#xD;
      improve prognosis of primary PCI through reducing distal embolization and no-reflow&#xD;
      phenomenon. There is no randomized clinical trial focuses on the effect and outcome of&#xD;
      deferred stent implantation on primary PCI for left main coronary artery occlusion in&#xD;
      contrast with conventional strategy.&#xD;
&#xD;
      This prospective, multicenter, randomized trial is aimed to compare immediate stenting with&#xD;
      deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether&#xD;
      deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left&#xD;
      main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of cardiac death and recurrent myocardial infarction</measure>
    <time_frame>30 days after primary angiography</time_frame>
    <description>Recorded in follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization</measure>
    <time_frame>30 days after primary angiography</time_frame>
    <description>Recorded in follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual stenosis of left main coronary artery</measure>
    <time_frame>Immediately after stent implantation and 12 months after primary angiography</time_frame>
    <description>Measured through angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular ejection fraction</measure>
    <time_frame>30 days and 12 months after primary angiography</time_frame>
    <description>Measured through echocardiogram</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Deferred stent implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate stent implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deferred stent implantation</intervention_name>
    <description>Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.</description>
    <arm_group_label>Deferred stent implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Immediate stent implantation</intervention_name>
    <description>Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.</description>
    <arm_group_label>Immediate stent implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of acute myocardial infarction occured within 12 hours&#xD;
&#xD;
          -  Left main coronary artery occlusion confirmed by angiography&#xD;
&#xD;
          -  Left main coronary artery occlusion (TIMI flow 0,1 or 2) confirmed by primary&#xD;
             angiography, TIMI flow grade 3 achieved after pretreatment of thrombus aspiration or&#xD;
             balloon dilatation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy less than 1 years&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Chronic kidney disease, stage 4 by KDOQI(GFR&lt;30ml/min)&#xD;
&#xD;
          -  Contraindications to aspirin or other anti-platelet drugs&#xD;
&#xD;
          -  Allergy to contrast agent, rapamycin or paclitaxel&#xD;
&#xD;
          -  Patients who are included in other ongoing trials&#xD;
&#xD;
          -  Pregnant female&#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>Junbo Ge, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Hospital,Shanghai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Feng Zhang, M.D.</last_name>
    <phone>13917149007</phone>
    <email>zhang.feng@zs-hospital.sh.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yang Gao, M.D.</last_name>
    <phone>18801970322</phone>
    <email>gysc20@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Zhang, M.D.</last_name>
      <phone>13917149007</phone>
      <email>zhang.feng@zs-hospital.sh.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yang Gao, M.D.</last_name>
      <phone>18801970322</phone>
      <email>gysc20@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Junbo Ge, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Feng Zhang, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang Gao, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>November 18, 2017</last_update_submitted>
  <last_update_submitted_qc>November 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute myocardial infarction</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <keyword>deferred stent implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Coronary Occlusion</mesh_term>
    <mesh_term>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/NCT03282773
org study id: B2017-104
nct id: NCT03282773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will compare clinical outcomes of immediate stent implantation with deferred stent
      implantation(4-10days after primary angiography) for patients presented with acute myocardial
      infarction due to left main coronary artery occlusion.
Primary percutaneous coronary intervention for patients presented with acute myocardial
      infarction caused by left main coronary artery occlusion is associated with significantly
      higher mortality and risks of major cardiac adverse events. Deferred stent implantation may
      improve prognosis of primary PCI through reducing distal embolization and no-reflow
      phenomenon. There is no randomized clinical trial focuses on the effect and outcome of
      deferred stent implantation on primary PCI for left main coronary artery occlusion in
      contrast with conventional strategy.

      This prospective, multicenter, randomized trial is aimed to compare immediate stenting with
      deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether
      deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left
      main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite of cardiac death and recurrent myocardial infarction
time frame: 30 days after primary angiography
description: Recorded in follow-up
measure: All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization
time frame: 30 days after primary angiography
description: Recorded in follow-up
measure: Residual stenosis of left main coronary artery
time frame: Immediately after stent implantation and 12 months after primary angiography
description: Measured through angiography
measure: Left ventricular ejection fraction
time frame: 30 days and 12 months after primary angiography
description: Measured through echocardiogram
arm group label: Deferred stent implantation
arm group type: Experimental
description: Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI
arm group label: Immediate stent implantation
arm group type: Active Comparator
description: Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery
intervention type: Device
intervention name: Deferred stent implantation
description: Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.
arm group label: Deferred stent implantation
intervention type: Device
intervention name: Immediate stent implantation
description: Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.
arm group label: Immediate stent implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Junbo Ge, M.D.
role: Principal Investigator
affiliation: Zhongshan Hospital,Shanghai
last name: Feng Zhang, M.D.
phone: 13917149007
email: zhang.feng@zs-hospital.sh.cn
last name: Yang Gao, M.D.
phone: 18801970322
email: gysc20@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Coronary Occlusion
mesh term: Infarction