<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/NCT02226900</url>
  </required_header>
  <id_info>
    <org_study_id>MERGING</org_study_id>
    <nct_id>NCT02226900</nct_id>
  </id_info>
  <brief_title>Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease</brief_title>
  <acronym>MERGING</acronym>
  <official_title>Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InCor Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>InCor Heart Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid&#xD;
      myocardial revascularization strategy (coronary artery by-pass graft and percutaneous&#xD;
      intervention) in comparison with conventional surgical coronary bypass grafting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">December 2018</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>Feasibility of Revascularization Procedure Proposed by the Heart Team</measure>
    <time_frame>30 days</time_frame>
    <description>The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>1 year</time_frame>
    <description>Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>2 years</time_frame>
    <description>Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>3 years</time_frame>
    <description>Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>4 years</time_frame>
    <description>Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>5 years</time_frame>
    <description>Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>180 days</time_frame>
    <description>Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>1 year</time_frame>
    <description>Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Angina</measure>
    <time_frame>1 year</time_frame>
    <description>Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Impact</measure>
    <time_frame>1 year</time_frame>
    <description>Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>1 year</time_frame>
    <description>Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Events</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft Patency</measure>
    <time_frame>1 year</time_frame>
    <description>Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical and Angiographic Scores Correlation with Prognostic</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate the clinical correlation between the revascularization strategy and the usefulness of the SYNTAX score, ACEF score, clinical SYNTAX score, logistic EuroSCORE, STS score and InsCor for prognostic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the Strategy</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic Graft Occlusion</measure>
    <time_frame>1 Year</time_frame>
    <description>Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life.</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cost</measure>
    <time_frame>5 years</time_frame>
    <description>Evaluate and compare the final cost of the procedure and follow up period of the patients enrolled in each one of the strategies.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital Stay</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate and compare the period of hospital stay of the patients enrolled in each one of the strategies.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Multivessel Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Hybrid Revascularization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The hybrid myocardial revascularization group will be accomplished by a two-step scheme, comprised by off-pump LIMA-to-left anterior descending grafting, followed by percutaneous coronary interventions with Promus Element (everolimus second generation drug eluting stent) for the remaining coronary lesions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Surgical Coronary Bypass Grafting</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional Coronary Artery Bypass Grafts with in pump technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hybrid Revascularization</intervention_name>
    <description>Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.</description>
    <arm_group_label>Hybrid Revascularization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Coronary Artery Bypass Surgery</intervention_name>
    <description>On pump coronary artery by-pass surgery</description>
    <arm_group_label>Conventional Surgical Coronary Bypass Grafting</arm_group_label>
    <other_name>Surgery</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Triple-vessel disease with proximal or mid LAD disease with angiographic diameter&#xD;
             stenosis &gt; 70% by visual analysis in all three territories, requiring myocardial&#xD;
             revascularization OR triple-vessel disease with proximal or mid LAD disease with&#xD;
             angiographic diameter stenosis 50-70% by visual analysis in any territory but with&#xD;
             invasive or non-invasive evidence of flow-limiting stenosis in all three territories,&#xD;
             requiring myocardial revascularization&#xD;
&#xD;
          -  Total SYNTAX score &gt; 22&#xD;
&#xD;
          -  LCx and RCA territories estimated to be equivalently revascularized by either PCI or&#xD;
             CABG, with at least one major non-LAD vessel to be treated&#xD;
&#xD;
          -  Clinical and anatomic eligibility for both PCI and CABG as agreed to by both&#xD;
             interventional and surgical consensus&#xD;
&#xD;
               -  Interventionalist determines PCI appropriateness and eligibility&#xD;
&#xD;
               -  Surgeon determines surgical appropriateness and eligibility&#xD;
&#xD;
          -  Silent ischemia, stable angina, unstable angina or recent MI&#xD;
&#xD;
               -  If recent MI, cardiac biomarkers must have returned to normal prior to&#xD;
                  randomization&#xD;
&#xD;
          -  Ability to sign informed consent and comply with all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior PCI or CABG at any time prior to randomization&#xD;
&#xD;
          -  Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic&#xD;
             repair, etc.), or intent that if the patient randomizes to surgery, any cardiac&#xD;
             surgical procedure other than isolated CABG will be performed&#xD;
&#xD;
          -  Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at&#xD;
             least one year&#xD;
&#xD;
          -  Patients requiring additional surgery (cardiac or non cardiac) within one year&#xD;
&#xD;
          -  The presence of any clinical or anatomical condition(s) which leads the participating&#xD;
             interventional cardiologist to believe that clinical equipoise is not present (i.e.&#xD;
             the patient should not be treated by PCI, but rather should be managed with CABG or&#xD;
             medical therapy - reasons will be documented)&#xD;
&#xD;
          -  The presence of any clinical or anatomical condition(s) which leads the participating&#xD;
             cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient&#xD;
             should not be treated by CABG, but rather should be managed with PCI. or medical&#xD;
             therapy - reasons will be documented)&#xD;
&#xD;
          -  Non cardiac co-morbidities with life expectancy less than 1 year&#xD;
&#xD;
          -  Other investigational drug or device studies that have not reached their primary&#xD;
             endpoint.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>InCor -Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>InCor Heart Institute</investigator_affiliation>
    <investigator_full_name>Pedro A. Lemos</investigator_full_name>
    <investigator_title>Pedro A. Lemos, Professor of Medicine, InCor Heart Institute</investigator_title>
  </responsible_party>
  <keyword>Multivessel Coronary Artery Disease</keyword>
  <keyword>Hybrid Revascularization</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>
  <!-- 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/NCT02226900
org study id: MERGING
nct id: NCT02226900
lead sponsor: 
collaborator: 
has dmc: No
This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid
      myocardial revascularization strategy (coronary artery by-pass graft and percutaneous
      intervention) in comparison with conventional surgical coronary bypass grafting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of Revascularization Procedure Proposed by the Heart Team
time frame: 30 days
description: The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.
measure: Major Adverse Cardiovascular Events
time frame: 1 year
description: Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
measure: Major Adverse Cardiovascular Events
time frame: 2 years
description: Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
measure: Major Adverse Cardiovascular Events
time frame: 3 years
description: Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
measure: Major Adverse Cardiovascular Events
time frame: 4 years
description: Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
measure: Major Adverse Cardiovascular Events
time frame: 5 years
description: Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
measure: Major Adverse Cardiovascular Events
time frame: 180 days
description: Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
measure: Safety
time frame: 1 year
description: Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.
measure: Recurrence of Angina
time frame: 1 year
description: Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
measure: Medication Impact
time frame: 1 year
description: Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.
measure: Stent Thrombosis
time frame: 1 year
description: Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria
measure: Bleeding
time frame: 1 year
description: Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria
measure: Neurological Events
time frame: 1 year
description: Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.
measure: Graft Patency
time frame: 1 year
description: Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography
measure: Clinical and Angiographic Scores Correlation with Prognostic
time frame: 1 year
description: Evaluate the clinical correlation between the revascularization strategy and the usefulness of the SYNTAX score, ACEF score, clinical SYNTAX score, logistic EuroSCORE, STS score and InsCor for prognostic evaluation
measure: Efficacy of the Strategy
time frame: 1 year
description: Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies.
measure: Symptomatic Graft Occlusion
time frame: 1 Year
description: Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography.
measure: Quality of life.
time frame: 5 years
measure: Cost
time frame: 5 years
description: Evaluate and compare the final cost of the procedure and follow up period of the patients enrolled in each one of the strategies.
measure: Hospital Stay
time frame: 1 year
description: Evaluate and compare the period of hospital stay of the patients enrolled in each one of the strategies.
arm group label: Hybrid Revascularization
arm group type: Experimental
description: The hybrid myocardial revascularization group will be accomplished by a two-step scheme, comprised by off-pump LIMA-to-left anterior descending grafting, followed by percutaneous coronary interventions with Promus Element (everolimus second generation drug eluting stent) for the remaining coronary lesions.
arm group label: Conventional Surgical Coronary Bypass Grafting
arm group type: Other
description: Conventional Coronary Artery Bypass Grafts with in pump technique.
intervention type: Procedure
intervention name: Hybrid Revascularization
description: Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.
arm group label: Hybrid Revascularization
intervention type: Procedure
intervention name: Conventional Coronary Artery Bypass Surgery
description: On pump coronary artery by-pass surgery
arm group label: Conventional Surgical Coronary Bypass Grafting
other name: Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: InCor Heart Institute
investigator full name: Pedro A. Lemos
investigator title: Pedro A. Lemos, Professor of Medicine, InCor Heart Institute
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease