xml: <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/NCT05982366</url>
    </required_header>
    <id_info>
      <org_study_id>AntaresStudy01</org_study_id>
      <nct_id>NCT05982366</nct_id>
    </id_info>
    <brief_title>Feasibility and Safety of the Routine Distal Transradial Approach</brief_title>
    <acronym>ANTARES</acronym>
    <official_title>distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Łukasz Koziński</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński</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>
        The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more&#xD;
        beneficial than the conventional transradial access (cTRA) in patients undergoing coronary&#xD;
        procedures. This prospective single-center randomized trial was designed to investigate the&#xD;
        safety, efficacy, and various ultrasound parameters of dTRA.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and&#xD;
        elective coronary procedures. The advantages of TRA compared to the transfemoral access&#xD;
        encompass a reduction of mortality, complications, and cost as well as improvement of&#xD;
        patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial&#xD;
        Access for coRonary procEdures Study) was to assess the feasibility, safety and various&#xD;
        ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in&#xD;
        comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous&#xD;
        coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial.&#xD;
        There are two arms: distal transradial access and conventional transradial approach.&#xD;
  &#xD;
        400 patients were enrolled.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Actual">May 31, 2023</completion_date>
    <primary_completion_date type="Actual">February 28, 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>
      <intervention_model_description>Prospective, single-center, randomized trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.</measure>
      <time_frame>up to 24 hours</time_frame>
      <description>Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.&#xD;
  Access-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm).&#xD;
  MACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>efficacy endpoint: rate of access crossover</measure>
      <time_frame>during the procedure index</time_frame>
      <description>Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>safety endpoint: patients' discomfort evaluated during access performance</measure>
      <time_frame>during the procedure</time_frame>
      <description>physical discomfort at the time of vascular access performance was assessed using a numerical scale (0/1/2/3 - respectively no/mild/moderate/severe discomfort)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>efficacy endpoint: duration of access performance</measure>
      <time_frame>during the procedure index</time_frame>
      <description>(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>safety endpoint: access-site vascular complications</measure>
      <time_frame>after 24 hours post procedure</time_frame>
      <description>it is composed by the rate of radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm; measured with Doppler Ultrasound</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Access-time</measure>
      <time_frame>during procedure</time_frame>
      <description>counted from local anesthesia to successful insertion of the sheath</description>
    </other_outcome>
    <other_outcome>
      <measure>radial artery size</measure>
      <time_frame>before the procedure, 24 hours and 60 days after the procedure</time_frame>
      <description>parameter measured by Doppler Ultrasound at the access point</description>
    </other_outcome>
    <other_outcome>
      <measure>radial artery velocity</measure>
      <time_frame>before the procedure, 24 hours and 60 days after the procedure</time_frame>
      <description>parameter measured by Doppler Ultrasound at the access point</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">400</enrollment>
    <condition>Vascular Access Complication</condition>
    <condition>Radial Artery</condition>
    <condition>Coronary Artery Disease</condition>
    <condition>Puncture</condition>
    <condition>Coronary Angiography</condition>
    <arm_group>
      <arm_group_label>Distal transradial approach</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Distal transradial approach as the default strategy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional transradial approach</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conventional transradial approach as the default strategy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>distal radial artery acess side</intervention_name>
      <description>coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area</description>
      <arm_group_label>Distal transradial approach</arm_group_label>
      <other_name>dTRA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>conventional radial artery acess side</intervention_name>
      <description>coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area</description>
      <arm_group_label>Conventional transradial approach</arm_group_label>
      <other_name>cTRA</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients referred for CAG and/or PCI&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ST-elevation myocardial infarction&#xD;
  &#xD;
            -  sudden cardiac arrest&#xD;
  &#xD;
            -  hemody-namic instability&#xD;
  &#xD;
            -  chronic kidney disease (stages 4-5)&#xD;
  &#xD;
            -  forearm artery occlusion&#xD;
  &#xD;
            -  previous unsuccessful ipsilateral TRA&#xD;
  &#xD;
            -  unfavorable RA diameter&#xD;
  &#xD;
            -  ultrasound unavailability&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Łukasz Koziński, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Szpital Specjalistyczny</name>
        <address>
          <city>Chojnice</city>
          <state>Pomeranian</state>
          <zip>89-600</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński</investigator_affiliation>
      <investigator_full_name>Łukasz Koziński</investigator_full_name>
      <investigator_title>Principal Investigator Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński</investigator_title>
    </responsible_party>
    <keyword>radial artery</keyword>
    <keyword>distal transradial approach</keyword>
    <keyword>access complication</keyword>
    <keyword>anatomical snuffbox</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982366
  org study id: AntaresStudy01
  nct id: NCT05982366
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more
        beneficial than the conventional transradial access (cTRA) in patients undergoing coronary
        procedures. This prospective single-center randomized trial was designed to investigate the
        safety, efficacy, and various ultrasound parameters of dTRA.
  Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and
        elective coronary procedures. The advantages of TRA compared to the transfemoral access
        encompass a reduction of mortality, complications, and cost as well as improvement of
        patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial
        Access for coRonary procEdures Study) was to assess the feasibility, safety and various
        ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in
        comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous
        coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial.
        There are two arms: distal transradial access and conventional transradial approach.
  
        400 patients were enrolled.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, single-center, randomized trial
  primary purpose: Other
  masking: None (Open Label)
  measure: The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
  time frame: up to 24 hours
  description: Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
  Access-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm).
  MACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death.
  measure: efficacy endpoint: rate of access crossover
  time frame: during the procedure index
  description: Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
  measure: safety endpoint: patients' discomfort evaluated during access performance
  time frame: during the procedure
  description: physical discomfort at the time of vascular access performance was assessed using a numerical scale (0/1/2/3 - respectively no/mild/moderate/severe discomfort)
  measure: efficacy endpoint: duration of access performance
  time frame: during the procedure index
  description: (measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)
  measure: safety endpoint: access-site vascular complications
  time frame: after 24 hours post procedure
  description: it is composed by the rate of radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm; measured with Doppler Ultrasound
  measure: Access-time
  time frame: during procedure
  description: counted from local anesthesia to successful insertion of the sheath
  measure: radial artery size
  time frame: before the procedure, 24 hours and 60 days after the procedure
  description: parameter measured by Doppler Ultrasound at the access point
  measure: radial artery velocity
  time frame: before the procedure, 24 hours and 60 days after the procedure
  description: parameter measured by Doppler Ultrasound at the access point
  arm group label: Distal transradial approach
  arm group type: Experimental
  description: Distal transradial approach as the default strategy
  arm group label: Conventional transradial approach
  arm group type: Active Comparator
  description: Conventional transradial approach as the default strategy
  intervention type: Other
  intervention name: distal radial artery acess side
  description: coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area
  arm group label: Distal transradial approach
  other name: dTRA
  intervention type: Other
  intervention name: conventional radial artery acess side
  description: coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area
  arm group label: Conventional transradial approach
  other name: cTRA
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Łukasz Koziński, MD
  role: Study Chair
  affiliation: Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński
  facility: 
  country: Poland
  responsible party type: Sponsor-Investigator
  investigator affiliation: Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński
  investigator full name: Łukasz Koziński
  investigator title: Principal Investigator Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński
  mesh term: Coronary Artery Disease
  sharing ipd: No