<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/NCT03027752</url>
  </required_header>
  <id_info>
    <org_study_id>N-RICP-346</org_study_id>
    <nct_id>NCT03027752</nct_id>
  </id_info>
  <brief_title>Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery</brief_title>
  <official_title>The New Technique of Carotid Endarterectomy With Autoarterial Remodeling of Bifurcation of the Common Carotid Artery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of two methods for revascularization of the bifurcation of common carotid artery:&#xD;
      carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty&#xD;
      compared with new technique of carotid endarterectomy with autoarterial remodeling of&#xD;
      bifurcation of the common carotid artery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke or TIA</measure>
    <time_frame>throughout 1 year</time_frame>
    <description>according to the examination of neurologist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Restenosis</measure>
    <time_frame>1 year</time_frame>
    <description>The percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Restenosis</measure>
    <time_frame>6 months</time_frame>
    <description>The percentage narrowing of the lumen at the bifurcation of the carotid artery at 6 months after surgery according to the ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>paresis of the cranial nerve</measure>
    <time_frame>up to 1 weeks</time_frame>
    <description>Neurological status after surgical treatment according to the examination of neurologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The linear flow velocity in the region of the carotid artery bifurcation</measure>
    <time_frame>3rd day</time_frame>
    <description>The linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The linear flow velocity in the region of the carotid artery bifurcation</measure>
    <time_frame>6 months</time_frame>
    <description>The linear velocity of blood flow in the bifurcation of the carotid artery after 6 months according to the ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The linear flow velocity in the region of the carotid artery bifurcation</measure>
    <time_frame>1 year</time_frame>
    <description>The linear velocity of blood flow in the bifurcation of the carotid artery after 1 year according to the ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bleeding</measure>
    <time_frame>1 month</time_frame>
    <description>30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stenosis</measure>
    <time_frame>3rd day</time_frame>
    <description>The percentage narrowing of the lumen at the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation of the brain</measure>
    <time_frame>during the surgical intervention</time_frame>
    <description>according to transcranial oximetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation of the brain</measure>
    <time_frame>6 months</time_frame>
    <description>according to transcranial oximetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation of the brain</measure>
    <time_frame>1 year</time_frame>
    <description>according to transcranial oximetry</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Stenosis, Internal Carotid Artery</condition>
  <arm_group>
    <arm_group_label>carotid endarterectomy patch angioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carotid endarterectomy with autoarterial remodeling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Operation carotid endarterectomy with plastic of xenopericardial patch</intervention_name>
    <description>Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds.</description>
    <arm_group_label>carotid endarterectomy patch angioplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA</intervention_name>
    <description>Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles.</description>
    <arm_group_label>Carotid endarterectomy with autoarterial remodeling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stenotic lesions of the extracranial part of carotid arteries requiring surgical&#xD;
             treatment according to national treatment guidelines (asymptomatic ICA stenosis more&#xD;
             than 70% symptomatic ICA stenosis more than 65%)&#xD;
&#xD;
          -  the length of the atherosclerotic plaques in the ICA than 1 cm&#xD;
&#xD;
          -  personally signed Informed consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic heart failure III-IV functional class NYHA classification&#xD;
&#xD;
          -  Chronic decompensated &quot;lung&quot; heart&#xD;
&#xD;
          -  Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l)&#xD;
&#xD;
          -  Severe hepatic or renal insufficiency (bilirubin &gt;80 mmol/l, creatinine &gt;200 mmol/l)&#xD;
&#xD;
          -  Polyvalent drug Allergy;&#xD;
&#xD;
          -  Malignant tumor in the terminal stage with life expectancy of up to 6 months;&#xD;
&#xD;
          -  Acute disruption of cerebral blood flow&#xD;
&#xD;
          -  Extensive occlusion of the internal carotid artery.&#xD;
&#xD;
          -  Exacerbation of systemic diseases.&#xD;
&#xD;
          -  Pregnancy and lactation.&#xD;
&#xD;
          -  The refusal of a patient to sign informed consent for participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novosibirsk Research Institute of Circulation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>October 25, 2018</last_update_submitted>
  <last_update_submitted_qc>October 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>carotid endaretectomy</keyword>
  <!-- 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/NCT03027752
org study id: N-RICP-346
nct id: NCT03027752
lead sponsor: 
has dmc: No
Comparison of two methods for revascularization of the bifurcation of common carotid artery:
      carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty
      compared with new technique of carotid endarterectomy with autoarterial remodeling of
      bifurcation of the common carotid artery
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Stroke or TIA
time frame: throughout 1 year
description: according to the examination of neurologist
measure: Restenosis
time frame: 1 year
description: The percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound
measure: Restenosis
time frame: 6 months
description: The percentage narrowing of the lumen at the bifurcation of the carotid artery at 6 months after surgery according to the ultrasound
measure: paresis of the cranial nerve
time frame: up to 1 weeks
description: Neurological status after surgical treatment according to the examination of neurologist
measure: The linear flow velocity in the region of the carotid artery bifurcation
time frame: 3rd day
description: The linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound
measure: The linear flow velocity in the region of the carotid artery bifurcation
time frame: 6 months
description: The linear velocity of blood flow in the bifurcation of the carotid artery after 6 months according to the ultrasound
measure: The linear flow velocity in the region of the carotid artery bifurcation
time frame: 1 year
description: The linear velocity of blood flow in the bifurcation of the carotid artery after 1 year according to the ultrasound
measure: bleeding
time frame: 1 month
description: 30 days after surgery
measure: Stenosis
time frame: 3rd day
description: The percentage narrowing of the lumen at the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound
measure: Oxygenation of the brain
time frame: during the surgical intervention
description: according to transcranial oximetry
measure: Oxygenation of the brain
time frame: 6 months
description: according to transcranial oximetry
measure: Oxygenation of the brain
time frame: 1 year
description: according to transcranial oximetry
arm group label: carotid endarterectomy patch angioplasty
arm group type: Active Comparator
description: Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty
arm group label: Carotid endarterectomy with autoarterial remodeling
arm group type: Experimental
description: Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery
intervention type: Procedure
intervention name: Operation carotid endarterectomy with plastic of xenopericardial patch
description: Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds.
arm group label: carotid endarterectomy patch angioplasty
intervention type: Procedure
intervention name: New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA
description: Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles.
arm group label: Carotid endarterectomy with autoarterial remodeling
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor