<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/NCT04439513</url>
  </required_header>
  <id_info>
    <org_study_id>EASY-RAO</org_study_id>
    <secondary_id>2020-3400, 21885</secondary_id>
    <nct_id>NCT04439513</nct_id>
  </id_info>
  <brief_title>Dual Artery Compression vs. Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EASY-RAO)</brief_title>
  <acronym>EASY-RAO</acronym>
  <official_title>Randomized Comparison f Dual Artery Compression Versus Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EArly Discharge After Transradial Stenting of coronarY Arteries - EASY-RAO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olivier F. Bertrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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>
      This study aims to demonstrate the superiority in clinical performances of a dual artery&#xD;
      compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device&#xD;
      (HemoSTOP).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of RAO after transradial approach (TRA) at hospital discharge</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of radial artery patent-hemostasis during hemostasis</measure>
    <time_frame>throughout intervention, up to 180 minutes</time_frame>
    <description>To determine the conservation of blood flow through the radial artery during compressive hemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient comfort during hemostasis as assessed on a visual scale</measure>
    <time_frame>throughout intervention, up to 30 days</time_frame>
    <description>To evaluate the level of patient comfort in relation to the device used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of complications such as repeat bleeding and hematoma (EASY Scale)</measure>
    <time_frame>throughout intervention, up to 30 days</time_frame>
    <description>To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nursing involvement in hemostasis management for sensitivity analysis on cost assessment</measure>
    <time_frame>throughout intervention, up to 24 hours</time_frame>
    <description>To determine the overall nursing involvement (time per nurse per patient) in hemostasis monitoring from end of procedure to patient discharge for a cost-benefit evaluation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Radial Artery Injury</condition>
  <arm_group>
    <arm_group_label>Dual Artery Compression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>time to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radial Artery-Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>time to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hemostasis</intervention_name>
    <description>Compression device to achieve hemostasis.</description>
    <arm_group_label>Dual Artery Compression</arm_group_label>
    <arm_group_label>Radial Artery-Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patients referred for diagnostic angiography and possible percutaneous coronary&#xD;
             intervention (PCI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to understand study design or objectives&#xD;
&#xD;
          -  Unable to sign informed consent&#xD;
&#xD;
          -  Patient taking warfarin or other anticoagulant therapy&#xD;
&#xD;
          -  Chronic RAO on both sides precluding TRA&#xD;
&#xD;
          -  Previous ipsilateral transradial approach&#xD;
&#xD;
          -  Inability to comply with the study follow-up&#xD;
&#xD;
          -  Presence of plethysmographic waveform with radial and ulnar occlusive compression&#xD;
&#xD;
          -  Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding&#xD;
             access-site evaluation.&#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_contact>
    <last_name>Olivier F Bertrand</last_name>
    <phone>4186568711</phone>
    <email>olivier.bertrand@crhl.ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michèle Jadin</last_name>
    <phone>4186568711</phone>
    <phone_ext>3007</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IUCPQ - Laval Hospital</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier F Bertrand, MD PhD</last_name>
      <phone>418 656 8711</phone>
      <email>olivier.bertrand@crhl.ulaval.ca</email>
    </contact>
    <investigator>
      <last_name>Olivier F Bertrand, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tomas Cieza, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Olivier F. Bertrand</investigator_full_name>
    <investigator_title>Director of the International Chair on Interventional Cardiology and Transradial Approach</investigator_title>
  </responsible_party>
  <keyword>RAO</keyword>
  <keyword>Hemostasis</keyword>
  <keyword>TRA</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatics</mesh_term>
  </intervention_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/NCT04439513
org study id: EASY-RAO
secondary id: 2020-3400, 21885
nct id: NCT04439513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to demonstrate the superiority in clinical performances of a dual artery
      compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device
      (HemoSTOP).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of RAO after transradial approach (TRA) at hospital discharge
time frame: up to 24 hours
description: To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.
measure: Percentage of radial artery patent-hemostasis during hemostasis
time frame: throughout intervention, up to 180 minutes
description: To determine the conservation of blood flow through the radial artery during compressive hemostasis
measure: Patient comfort during hemostasis as assessed on a visual scale
time frame: throughout intervention, up to 30 days
description: To evaluate the level of patient comfort in relation to the device used
measure: Rates of complications such as repeat bleeding and hematoma (EASY Scale)
time frame: throughout intervention, up to 30 days
description: To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated.
measure: Nursing involvement in hemostasis management for sensitivity analysis on cost assessment
time frame: throughout intervention, up to 24 hours
description: To determine the overall nursing involvement (time per nurse per patient) in hemostasis monitoring from end of procedure to patient discharge for a cost-benefit evaluation.
arm group label: Dual Artery Compression
arm group type: Experimental
description: time to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis.
arm group label: Radial Artery-Only
arm group type: Active Comparator
description: time to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis.
intervention type: Device
intervention name: Hemostasis
description: Compression device to achieve hemostasis.
arm group label: Dual Artery Compression
arm group label: Radial Artery-Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier F Bertrand
phone: 4186568711
email: olivier.bertrand@crhl.ulaval.ca
last name: Michèle Jadin
phone: 4186568711
phone ext: 3007
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Laval University
investigator full name: Olivier F. Bertrand
investigator title: Director of the International Chair on Interventional Cardiology and Transradial Approach
mesh term: Hemostatics
sharing ipd: No