<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/NCT03753048</url>
  </required_header>
  <id_info>
    <org_study_id>TAR</org_study_id>
    <nct_id>NCT03753048</nct_id>
  </id_info>
  <brief_title>Total Arterial Revascularization (TAR)</brief_title>
  <official_title>Comparison of Total Arterial Revascularization of Y-Graft Versus In-Situ Configuration Using Bilateral Internal Thoracic Arteries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kemerovo Cardiology Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</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>
      Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft&#xD;
      in patients underwent CABG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic&#xD;
      arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction,&#xD;
      repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is&#xD;
      shedueled for CABG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 13, 2018</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from MACCE</measure>
    <time_frame>5 years</time_frame>
    <description>Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graft patency</measure>
    <time_frame>5 years</time_frame>
    <description>Graft patency in 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36)</measure>
    <time_frame>5 years</time_frame>
    <description>Assessment of the patient's quality of life by the Short Form-36 in 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treadmill stress test</measure>
    <time_frame>5 years</time_frame>
    <description>Non-invasive diagnosis of myocardial ischemia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">880</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Artery Bypass Grafting</condition>
  <arm_group>
    <arm_group_label>Y-Graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group includes patients who underwent CABG in Y-Graft Configuration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-Situ</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group includes patients who underwent CABG in In-Situ Configuration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Y-Graft</intervention_name>
    <description>Y-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.</description>
    <arm_group_label>Y-Graft</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>In-Situ</intervention_name>
    <description>In-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.</description>
    <arm_group_label>In-Situ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Coronary Artery Disease&#xD;
&#xD;
          -  Stable angina&#xD;
&#xD;
          -  The need for revascularization of anterior descending and obtuse margin arteries&#xD;
             accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization&#xD;
&#xD;
          -  Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The diameter of the target arteries is less than 1 mm&#xD;
&#xD;
          -  Stenosis of the subclavian arteries more than 60%&#xD;
&#xD;
          -  STEMI less than 3 month&#xD;
&#xD;
          -  Previous cardiac surgery&#xD;
&#xD;
          -  BMI &gt;35&#xD;
&#xD;
          -  COPD with FEV1 &lt;60%&#xD;
&#xD;
          -  Concomitant pathology that requires simultaneous surgical treatment&#xD;
&#xD;
          -  Cancer with life expectancy less than 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dmitry Sirota, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meshalkin National Medical Research Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dmitry A Sirota, MD</last_name>
    <phone>+79132012140</phone>
    <email>sirotad@yandex.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meshalkin National Medical Research Center</name>
      <address>
        <city>Novosibirsk</city>
        <state>Novosibirsk Region</state>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dmitry A Sirota, MD</last_name>
      <phone>+79132012140</phone>
      <email>sirotad@yandex.ru</email>
    </contact>
    <contact_backup>
      <last_name>Dmitry Khvan</last_name>
      <phone>+79069090505</phone>
      <email>dmhvan@mail.ru</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meshalkin Research Institute of Pathology of Circulation</investigator_affiliation>
    <investigator_full_name>Dmitry Sirota</investigator_full_name>
    <investigator_title>Head of the surgery of aorta and coronary arteries department</investigator_title>
  </responsible_party>
  <keyword>Total Arterial Revascularization</keyword>
  <keyword>Y-Graft</keyword>
  <keyword>In-Situ</keyword>
  <keyword>Coronary Artery Bypass Grafting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery 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/NCT03753048
org study id: TAR
nct id: NCT03753048
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft
      in patients underwent CABG.
The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic
      arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction,
      repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is
      shedueled for CABG.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Freedom from MACCE
time frame: 5 years
description: Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)
measure: Graft patency
time frame: 5 years
description: Graft patency in 5 years
measure: Quality of life (SF-36)
time frame: 5 years
description: Assessment of the patient's quality of life by the Short Form-36 in 5 years
measure: Treadmill stress test
time frame: 5 years
description: Non-invasive diagnosis of myocardial ischemia
arm group label: Y-Graft
arm group type: Active Comparator
description: The group includes patients who underwent CABG in Y-Graft Configuration.
arm group label: In-Situ
arm group type: Active Comparator
description: The group includes patients who underwent CABG in In-Situ Configuration.
intervention type: Procedure
intervention name: Y-Graft
description: Y-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
arm group label: Y-Graft
intervention type: Procedure
intervention name: In-Situ
description: In-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
arm group label: In-Situ
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dmitry Sirota, MD
role: Principal Investigator
affiliation: Meshalkin National Medical Research Center
last name: Dmitry A Sirota, MD
phone: +79132012140
email: sirotad@yandex.ru
facility: 
status: Recruiting
contact: 
contact backup: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Meshalkin Research Institute of Pathology of Circulation
investigator full name: Dmitry Sirota
investigator title: Head of the surgery of aorta and coronary arteries department
mesh term: Coronary Artery Disease