<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/NCT03025685</url>
  </required_header>
  <id_info>
    <org_study_id>TRUST</org_study_id>
    <nct_id>NCT03025685</nct_id>
  </id_info>
  <brief_title>&quot;TransRadial Ultra Support Technique&quot; (TRUST)</brief_title>
  <official_title>&quot;TransRadial Ultra Support Technique&quot; (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study</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>
      Adequate support is required for challenging percutaneous coronary interventions (PCI). The&#xD;
      &quot;TransRadial Ultra Support Technique&quot; (TRUST technique) is a new support technique that&#xD;
      provides active support by deep pass of the coronary wire into the heart cavities (left&#xD;
      ventricle-LV, right ventricle-RV) or aorta.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Procedural success</measure>
    <time_frame>1 week after PCI</time_frame>
    <description>Device success without the occurrence of in-hospital MACCE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device success</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Achievement of a final residual diameter stenosis &lt;20% and a TIMI 3 flow in the target vessel</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Coronary Arterioscleroses</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>TRUST technique + Coronary Stenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PCI with coronary stenting using TransRadial Ultra Support technique for support improvement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anchoring technique + Coronary Stenting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PCI with coronary stenting using Wire Anchoring Pass technique for support improvement</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TRUST technique</intervention_name>
    <description>A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily</description>
    <arm_group_label>TRUST technique + Coronary Stenting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anchoring Technique</intervention_name>
    <description>A standard endovascular technique of coronary wire support improvement</description>
    <arm_group_label>Anchoring technique + Coronary Stenting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronary stenting</intervention_name>
    <description>A standard endovascular procedure of percutaneous coronary intervention with coronary stenting</description>
    <arm_group_label>Anchoring technique + Coronary Stenting</arm_group_label>
    <arm_group_label>TRUST technique + Coronary Stenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects singed informed consent form&#xD;
&#xD;
          -  Subjects eligible for percutaneous coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years or &gt;75 years&#xD;
&#xD;
          -  Subject has a platelet count &lt; 100,000 cells/mm3 or &gt; 700,000 cells/mm3.&#xD;
&#xD;
          -  Known non-adherence to double anti-platelet therapy (DAPT)&#xD;
&#xD;
          -  LVEF &lt;30%&#xD;
&#xD;
          -  Continuing bleeding&#xD;
&#xD;
          -  Acute coronary syndrome (ST-elevation Myocardial infarction)&#xD;
&#xD;
          -  Pregnancy&#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>State 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>December 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>December 24, 2017</last_update_submitted>
  <last_update_submitted_qc>December 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Wire</keyword>
  <keyword>Coronary stenting</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>Arteriosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025685
org study id: TRUST
nct id: NCT03025685
lead sponsor: 
has dmc: No
Adequate support is required for challenging percutaneous coronary interventions (PCI). The
      "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that
      provides active support by deep pass of the coronary wire into the heart cavities (left
      ventricle-LV, right ventricle-RV) or aorta.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedural success
time frame: 1 week after PCI
description: Device success without the occurrence of in-hospital MACCE
measure: Device success
time frame: Intraoperative
description: Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel
arm group label: TRUST technique + Coronary Stenting
arm group type: Experimental
description: PCI with coronary stenting using TransRadial Ultra Support technique for support improvement
arm group label: Anchoring technique + Coronary Stenting
arm group type: Active Comparator
description: PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
intervention type: Procedure
intervention name: TRUST technique
description: A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily
arm group label: TRUST technique + Coronary Stenting
intervention type: Procedure
intervention name: Anchoring Technique
description: A standard endovascular technique of coronary wire support improvement
arm group label: Anchoring technique + Coronary Stenting
intervention type: Procedure
intervention name: Coronary stenting
description: A standard endovascular procedure of percutaneous coronary intervention with coronary stenting
arm group label: Anchoring technique + Coronary Stenting
arm group label: TRUST technique + Coronary Stenting
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Arteriosclerosis
sharing ipd: No