<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/NCT01699048</url>
  </required_header>
  <id_info>
    <org_study_id>HREVS</org_study_id>
    <nct_id>NCT01699048</nct_id>
  </id_info>
  <brief_title>The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG</brief_title>
  <acronym>HREVS</acronym>
  <official_title>Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Russian Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Russian Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Minimally invasive revascularization of the left anterior descending artery followed by stent&#xD;
      implantation versus percutaneous coronary intervention or coronary artery bypass in patients&#xD;
      with multi-vessel coronary disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, single-center, randomized trial, intended to compare three revascularization&#xD;
      strategies in patients with multi-vessel coronary artery disease:&#xD;
&#xD;
        1. Hybrid approach (Minimally invasive off-pump revascularization of the left anterior&#xD;
           descending artery (LAD) with left internal mammary artery (LIMA) bypass followed by&#xD;
           consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with&#xD;
           drug eluting stents (DES) (Hybrid group, n=50)&#xD;
&#xD;
        2. Multi-vessel PCI with DES (MV-PCI group, n=50)&#xD;
&#xD;
        3. Coronary artery bypass graft (CABG) treatment (CABG group, n=50)&#xD;
&#xD;
      PCI in Hybrid and MV-PCI group will be performed with the same 2nd generation clinically&#xD;
      proven DES (Xience V, Xience Prime).&#xD;
&#xD;
      Study objective Compare three different revascularization strategies in patients with&#xD;
      multi-vessel coronary disease&#xD;
&#xD;
      The endpoints:&#xD;
&#xD;
      The primary endpoints:&#xD;
&#xD;
      I. % ischemic myocardium on a 12-month follow-up scan with single photon emission computed&#xD;
      tomography (SPECT);&#xD;
&#xD;
      The secondary endpoints:&#xD;
&#xD;
      I. Major adverse cardiac and cerebral events (MACCE), including (1) death, (2) non-fatal&#xD;
      myocardial infarction (non-fatal MI), transitory ischemic attack (TIA) or stroke within 30&#xD;
      days, 12 months and 5-year follow-up; II. Target vessel/graft failure (for any of the target&#xD;
      vessels in a given patient - stented or grafted) = a composite of cardiac death, MI&#xD;
      attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel&#xD;
      Revascularization (TVR); III. Restenosis = angiographically-detected target lesion stenosis&#xD;
      &gt;50% [diameter stenosis] or graft stenosis &gt;50%; IV. Procedural success: The treatment will&#xD;
      be considered successful when a revascularisation in the absence of complications during the&#xD;
      index hospitalization has been achieved; V. Procedural and post-procedural hemorrhagic&#xD;
      complications [ Time Frame: up to discharge from the hospital ]; VI. Recovery time [ Time&#xD;
      Frame: up to discharge from the hospital ];&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2012</start_date>
  <completion_date type="Actual">September 16, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</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>Residual ischemia</measure>
    <time_frame>6 - to 18-month follow-up</time_frame>
    <description>≥5% residual ischemia by single photon emission computed tomography (SPECT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACCE</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events:&#xD;
Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>up to discharge from the hospital</time_frame>
    <description>Procedural success: The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural and post-procedural blood loss and number of transfusions</measure>
    <time_frame>up to discharge from the hospital</time_frame>
    <description>dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery time</measure>
    <time_frame>up to discharge from the hospital</time_frame>
    <description>Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel/graft failure</measure>
    <time_frame>6- to 18-month follow-up</time_frame>
    <description>(for any of the target vessels in a given patient - stented or grafted) = a composite of cardiac death, MI attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel Revascularization (TVR);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Restenosis</measure>
    <time_frame>6- to 18-month follow-up</time_frame>
    <description>angiographically-detected target lesion stenosis &gt;50% [diameter stenosis] or graft stenosis &gt;50%;</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocardial Ischemia</condition>
  <condition>Coronary Disease</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Hybrid group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with the left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Multi-vessel PCI with DES (MV-PCI group, n=50)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CABG</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Coronary artery bypass graft (CABG) treatment (CABG group, n=50)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hybrid (MIDCAB+PCI)</intervention_name>
    <description>Hybrid approach (Minimally invasive of-pump revascularization of the left anterior descending artery (LAD) via left internal mammary artery (LIMA) bypass with consecutive percutaneous coronary intervention (PCI) in the rest arteries with drug eluting stents (DES). The revascularization will be performed in two stages within a 3-days interval</description>
    <arm_group_label>Hybrid group</arm_group_label>
    <other_name>MIDCAB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PCI</intervention_name>
    <description>Multi-vessel PCI with DES</description>
    <arm_group_label>PCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CABG</intervention_name>
    <description>Coronary artery bypass graft (CABG) treatment</description>
    <arm_group_label>CABG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Multi-vessel coronary artery disease with ≥ 70% and &lt;96% artery stenosis (according to&#xD;
             QCA)&#xD;
&#xD;
          2. I-IV CCS functional class of angina&#xD;
&#xD;
          3. Asymptomatic patients with stress-test documented ischemia.&#xD;
&#xD;
          4. Patients at 1 month after acute myocardial infarction&#xD;
&#xD;
          5. Ability to perform either of revascularization methods (Hybrid, MVD-PCI, CABG).&#xD;
&#xD;
          6. Consensus on the treatment strategy between the members of the working group,&#xD;
             including cardiologist, cardiac surgeon and interventional specialist.&#xD;
&#xD;
          7. Patients must have signed an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Acute coronary syndrome.&#xD;
&#xD;
          3. Previous CABG.&#xD;
&#xD;
          4. Previous stent thrombosis.&#xD;
&#xD;
          5. Severe comorbidity with high procedural risk for either of the studied strategies.&#xD;
&#xD;
          6. Severe peripheral artery disease.&#xD;
&#xD;
          7. Other serious diseases limiting life expectancy (e.g. oncology)&#xD;
&#xD;
          8. Inability for long-term follow-up.&#xD;
&#xD;
          9. Participation in other clinical trials.&#xD;
&#xD;
         10. Inability to take dual antithrombotic therapy.&#xD;
&#xD;
        Angiographic exclusion criteria&#xD;
&#xD;
          1. Critical stenosis (&gt;95%) in RCA,LAD, CX or Intermediate artery, feasible for&#xD;
             revascularization.&#xD;
&#xD;
          2. Stenosis of left main ≥ 50%.&#xD;
&#xD;
          3. Coronary artery occlusion of the major vessel.&#xD;
&#xD;
          4. Single vessel disease.&#xD;
&#xD;
          5. Need for emergency revascularization (ACS).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Institute of Complex Issues of Cardiovascular Diseases</name>
      <address>
        <city>Kemerovo</city>
        <state>Kemerovo region</state>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Russian Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Dr. Vladimir Ganyukov</investigator_full_name>
    <investigator_title>Hybrid minimally invasive and Interventional coronary revascularization in patients with Multi-vessel coronary artery disease versus complete Endovascular Revascularisation or coronary Artery bypass graft (treatment strategies).</investigator_title>
  </responsible_party>
  <keyword>multivessel PCI,MIDCAB,CABG</keyword>
  <keyword>Hybrid coronary 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>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Ischemia</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/NCT01699048
org study id: HREVS
nct id: NCT01699048
lead sponsor: 
has dmc: No
Minimally invasive revascularization of the left anterior descending artery followed by stent
      implantation versus percutaneous coronary intervention or coronary artery bypass in patients
      with multi-vessel coronary disease
Prospective, single-center, randomized trial, intended to compare three revascularization
      strategies in patients with multi-vessel coronary artery disease:

        1. Hybrid approach (Minimally invasive off-pump revascularization of the left anterior
           descending artery (LAD) with left internal mammary artery (LIMA) bypass followed by
           consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with
           drug eluting stents (DES) (Hybrid group, n=50)

        2. Multi-vessel PCI with DES (MV-PCI group, n=50)

        3. Coronary artery bypass graft (CABG) treatment (CABG group, n=50)

      PCI in Hybrid and MV-PCI group will be performed with the same 2nd generation clinically
      proven DES (Xience V, Xience Prime).

      Study objective Compare three different revascularization strategies in patients with
      multi-vessel coronary disease

      The endpoints:

      The primary endpoints:

      I. % ischemic myocardium on a 12-month follow-up scan with single photon emission computed
      tomography (SPECT);

      The secondary endpoints:

      I. Major adverse cardiac and cerebral events (MACCE), including (1) death, (2) non-fatal
      myocardial infarction (non-fatal MI), transitory ischemic attack (TIA) or stroke within 30
      days, 12 months and 5-year follow-up; II. Target vessel/graft failure (for any of the target
      vessels in a given patient - stented or grafted) = a composite of cardiac death, MI
      attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel
      Revascularization (TVR); III. Restenosis = angiographically-detected target lesion stenosis
      >50% [diameter stenosis] or graft stenosis >50%; IV. Procedural success: The treatment will
      be considered successful when a revascularisation in the absence of complications during the
      index hospitalization has been achieved; V. Procedural and post-procedural hemorrhagic
      complications [ Time Frame: up to discharge from the hospital ]; VI. Recovery time [ Time
      Frame: up to discharge from the hospital ];
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Residual ischemia
time frame: 6 - to 18-month follow-up
description: ≥5% residual ischemia by single photon emission computed tomography (SPECT)
measure: MACCE
time frame: up to 5 years
description: Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events:
Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.
measure: Procedural success
time frame: up to discharge from the hospital
description: Procedural success: The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.
measure: Procedural and post-procedural blood loss and number of transfusions
time frame: up to discharge from the hospital
description: dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC
measure: Recovery time
time frame: up to discharge from the hospital
description: Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission
measure: Target vessel/graft failure
time frame: 6- to 18-month follow-up
description: (for any of the target vessels in a given patient - stented or grafted) = a composite of cardiac death, MI attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel Revascularization (TVR);
measure: Restenosis
time frame: 6- to 18-month follow-up
description: angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%;
arm group label: Hybrid group
arm group type: Other
description: Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with the left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50)
arm group label: PCI
arm group type: Other
description: Multi-vessel PCI with DES (MV-PCI group, n=50)
arm group label: CABG
arm group type: Other
description: Coronary artery bypass graft (CABG) treatment (CABG group, n=50)
intervention type: Procedure
intervention name: Hybrid (MIDCAB+PCI)
description: Hybrid approach (Minimally invasive of-pump revascularization of the left anterior descending artery (LAD) via left internal mammary artery (LIMA) bypass with consecutive percutaneous coronary intervention (PCI) in the rest arteries with drug eluting stents (DES). The revascularization will be performed in two stages within a 3-days interval
arm group label: Hybrid group
other name: MIDCAB
intervention type: Procedure
intervention name: PCI
description: Multi-vessel PCI with DES
arm group label: PCI
intervention type: Procedure
intervention name: CABG
description: Coronary artery bypass graft (CABG) treatment
arm group label: CABG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Russian Academy of Medical Sciences
investigator full name: Dr. Vladimir Ganyukov
investigator title: Hybrid minimally invasive and Interventional coronary revascularization in patients with Multi-vessel coronary artery disease versus complete Endovascular Revascularisation or coronary Artery bypass graft (treatment strategies).
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Heart Diseases
mesh term: Ischemia