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/NCT05966376</url>
    </required_header>
    <id_info>
      <org_study_id>21-1255</org_study_id>
      <nct_id>NCT05966376</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization</brief_title>
    <acronym>HEMOSTAD-INC</acronym>
    <official_title>Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto Nacional de Cardiologia Ignacio Chavez</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto Nacional de Cardiologia Ignacio Chavez</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal&#xD;
        radial approach.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        INTRODUCTION AND BACKGROUND&#xD;
  &#xD;
        Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand&#xD;
        has currently positioned itself as a viable and safe approach for procedures in&#xD;
        interventional cardiology, whether diagnostic, simple, or complex angioplasties. We know that&#xD;
        this approach method mainly reduces the occlusion rate of the proximal radial artery, among&#xD;
        other advantages; however, we still do not have scientific evidence on the various hemostasis&#xD;
        methods for this approach. Practice varies between centers and countries and hemostasis&#xD;
        methods vary from an elastic compression bandage to the use of devices manufactured&#xD;
        specifically for this approach such as the PreludeSYNC DISTAL or modification of devices&#xD;
        manufactured for proximal radial hemostasis such as the TR band. In this clinical trial, we&#xD;
        intend to analyze the efficacy and safety of two hemostasis methods in patients who require&#xD;
        an interventional procedure (PredludeSYNC DISTAL vs modified TR band), to date, there is no&#xD;
        clinical trial that compares these methods face to-face in relation to their efficacy and&#xD;
        safety. Retrospective studies indicate that both methods are effective in reducing radial&#xD;
        artery occlusion and are safe in reducing the bleeding/hematoma rate.&#xD;
  &#xD;
        THE PURPOSE OF THE STUDY To compare the efficacy (distal radial artery occlusion) and safety&#xD;
        (hematoma/bleeding) of two devices of distal radial hemostasis (PreludeSYNC distal and TR&#xD;
        band) in patients undergoing percutaneous coronary intervention.&#xD;
  &#xD;
        STUDY DESIGN Experimental, randomized, prospective, longitudinal, prolective, and&#xD;
        comparative.&#xD;
  &#xD;
        SUBJECTS OF STUDY Patients from the Ignacio Chávez National Institute of Cardiology who will&#xD;
        undergo distal radial percutaneous coronary intervention/angiography.&#xD;
  &#xD;
        METHODOLOGY After signing the informed consent, patients will be randomized by balanced block&#xD;
        methods to: 1) Hemostasis using the PreludeSYNC distal device, or 2) Hemostasis using the&#xD;
        Modified Radial Band device.&#xD;
  &#xD;
        PRIMARY OUTCOME To compare the efficacy (distal radial artery occlusion) and safety&#xD;
        (hematoma/bleeding) of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial&#xD;
        approach.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.</measure>
      <time_frame>24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.</time_frame>
      <description>At 24 hours after the procedure, patients will be evaluated by interrogation, physical exam and ultrasonography. The absence of Doppler flow in the proximal radial artery at wrist level will define the occlusion of the radial artery. The EASY scale will be used to classify the severity of the hematoma in degrees from I to V according to the extension.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of distal and proximal radial artery occlusion at 24 hours after the procedure.</measure>
      <time_frame>24 hours after the procedure.</time_frame>
      <description>Evaluated by clinical signs and doppler.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radial arterial patency at 30 days in patients with obstruction at 24 hours.</measure>
      <time_frame>30 days after the procedure</time_frame>
      <description>Evaluated by clinical signs and ultrasound doppler.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of hematoma at the approach site.</measure>
      <time_frame>24 hours after the procedure.</time_frame>
      <description>Evaluated by clinical signs. Classified according to EASY scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding at the access site.</measure>
      <time_frame>24 hours after the procedure.</time_frame>
      <description>Evaluated by clinical signs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurological sequelae.</measure>
      <time_frame>24 hours after the procedure.</time_frame>
      <description>Evaluated by clinical signs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of radial artery pseudoaneurysms.</measure>
      <time_frame>24 hours after the procedure.</time_frame>
      <description>Evaluated by clinical signs and ultrasound doppler.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">482</enrollment>
    <condition>Coronary Intervention</condition>
    <condition>Transradial Approach</condition>
    <arm_group>
      <arm_group_label>Modified Terumo Radial Band</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A standard hemostatic device used for proximal radial approach. The hard plastic component is removed to achieve better attachment in the distal radial approach.&#xD;
  Clean and dry the puncture site.&#xD;
  The introducer is withdrawn 2 cm.&#xD;
  Place the device on the patient's hand depending on the approach side.&#xD;
  Terumo logo is positioned toward the little finger side.&#xD;
  The green mark is positioned 1 cm proximal to the puncture site.&#xD;
  The bands are adjusted and fixed around the wrist.&#xD;
  The Terumo syringe is filled with 15 ml of air.&#xD;
  The balloon of the device is slowly inflated through the valve while the introducer is slowly withdrawn simultaneously.&#xD;
  Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified.&#xD;
  Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon is inflated to achieve adequate hemostasis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PreludeSYNC distal</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A specific hemostatic device, designed for distal radial approach.&#xD;
  Clean and dry the puncture site.&#xD;
  Selection and preparation of the PreludeSYNC distal device according to the approach side.&#xD;
  The introducer is withdrawn 2cm.&#xD;
  The hemostasis device is placed on the patient's hand.&#xD;
  Bands position: 1) little finger side; 2) thumb side; 3) between the thumb and the index finger.&#xD;
  The circular mark of the balloon is positioned 1cm proximal to the puncture site.&#xD;
  Bands are adjusted and fixed.&#xD;
  The syringe is filled with 10 ml of air.&#xD;
  The balloon of the device is slowly inflated while the introducer is slowly withdrawn simultaneously.&#xD;
  Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified.&#xD;
  Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon should be inflated to achieve adequate hemostasis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hemostatic device for distal radial approach.</intervention_name>
      <description>Hemostasis after distal radial approach is done with one of two devices, one of them is designed specifically for the distal radial approach; the other is not but a modified technique with the last one could be helpful.</description>
      <arm_group_label>Modified Terumo Radial Band</arm_group_label>
      <arm_group_label>PreludeSYNC distal</arm_group_label>
      <other_name>PreludeSYNC distal</other_name>
      <other_name>Terumo Radial Band</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Coronary artery disease including chronic coronary syndrome or acute coronary&#xD;
               syndrome.&#xD;
  &#xD;
            -  Cardiovascular disease that requires coronary angiography in its approach.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiogenic shock.&#xD;
  &#xD;
            -  Lesions in venous or arterial hemoducts.&#xD;
  &#xD;
            -  Impossibility to provide informed consent.&#xD;
  &#xD;
            -  Chronic kidney disease on hemodialysis through arteriovenous fistula at the same site&#xD;
               where the approach is planned.&#xD;
  &#xD;
            -  Severe chronic renal failure (GFR less than 30 ml/min/m2)&#xD;
  &#xD;
            -  Patients diagnosed with cancer.&#xD;
  &#xD;
            -  Patient with rheumatological and hematological pro-thrombotic disorders.&#xD;
  &#xD;
            -  Non-hydrophilic radial introducer.&#xD;
  &#xD;
            -  Failed cannulation of the radial artery with an introducer.&#xD;
  &#xD;
            -  Successful trans-radial access that is crossed over to the femoral approach.&#xD;
  &#xD;
            -  Patients with an interventional procedure using a radial approach in the previous 30&#xD;
               days.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Instituto Nacional de Cardiologia Ignacio Chávez</name>
        <address>
          <city>Mexico City</city>
          <zip>14080</zip>
          <country>Mexico</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto Nacional de Cardiologia Ignacio Chavez</investigator_affiliation>
      <investigator_full_name>Arnoldo Enmanuel Loáisiga Sáenz</investigator_full_name>
      <investigator_title>Interventional Cardiology</investigator_title>
    </responsible_party>
    <keyword>Distal Radial Artery Access</keyword>
    <keyword>PreludeSYNC distal</keyword>
    <keyword>Terumo Radial Band</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemostatics</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05966376
  org study id: 21-1255
  nct id: NCT05966376
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal
        radial approach.
  INTRODUCTION AND BACKGROUND
  
        Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand
        has currently positioned itself as a viable and safe approach for procedures in
        interventional cardiology, whether diagnostic, simple, or complex angioplasties. We know that
        this approach method mainly reduces the occlusion rate of the proximal radial artery, among
        other advantages; however, we still do not have scientific evidence on the various hemostasis
        methods for this approach. Practice varies between centers and countries and hemostasis
        methods vary from an elastic compression bandage to the use of devices manufactured
        specifically for this approach such as the PreludeSYNC DISTAL or modification of devices
        manufactured for proximal radial hemostasis such as the TR band. In this clinical trial, we
        intend to analyze the efficacy and safety of two hemostasis methods in patients who require
        an interventional procedure (PredludeSYNC DISTAL vs modified TR band), to date, there is no
        clinical trial that compares these methods face to-face in relation to their efficacy and
        safety. Retrospective studies indicate that both methods are effective in reducing radial
        artery occlusion and are safe in reducing the bleeding/hematoma rate.
  
        THE PURPOSE OF THE STUDY To compare the efficacy (distal radial artery occlusion) and safety
        (hematoma/bleeding) of two devices of distal radial hemostasis (PreludeSYNC distal and TR
        band) in patients undergoing percutaneous coronary intervention.
  
        STUDY DESIGN Experimental, randomized, prospective, longitudinal, prolective, and
        comparative.
  
        SUBJECTS OF STUDY Patients from the Ignacio Chávez National Institute of Cardiology who will
        undergo distal radial percutaneous coronary intervention/angiography.
  
        METHODOLOGY After signing the informed consent, patients will be randomized by balanced block
        methods to: 1) Hemostasis using the PreludeSYNC distal device, or 2) Hemostasis using the
        Modified Radial Band device.
  
        PRIMARY OUTCOME To compare the efficacy (distal radial artery occlusion) and safety
        (hematoma/bleeding) of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial
        approach.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.
  time frame: 24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.
  description: At 24 hours after the procedure, patients will be evaluated by interrogation, physical exam and ultrasonography. The absence of Doppler flow in the proximal radial artery at wrist level will define the occlusion of the radial artery. The EASY scale will be used to classify the severity of the hematoma in degrees from I to V according to the extension.
  measure: Incidence of distal and proximal radial artery occlusion at 24 hours after the procedure.
  time frame: 24 hours after the procedure.
  description: Evaluated by clinical signs and doppler.
  measure: Radial arterial patency at 30 days in patients with obstruction at 24 hours.
  time frame: 30 days after the procedure
  description: Evaluated by clinical signs and ultrasound doppler.
  measure: Incidence of hematoma at the approach site.
  time frame: 24 hours after the procedure.
  description: Evaluated by clinical signs. Classified according to EASY scale.
  measure: Bleeding at the access site.
  time frame: 24 hours after the procedure.
  description: Evaluated by clinical signs.
  measure: Neurological sequelae.
  time frame: 24 hours after the procedure.
  description: Evaluated by clinical signs.
  measure: Incidence of radial artery pseudoaneurysms.
  time frame: 24 hours after the procedure.
  description: Evaluated by clinical signs and ultrasound doppler.
  arm group label: Modified Terumo Radial Band
  arm group type: Experimental
  description: A standard hemostatic device used for proximal radial approach. The hard plastic component is removed to achieve better attachment in the distal radial approach.
  Clean and dry the puncture site.
  The introducer is withdrawn 2 cm.
  Place the device on the patient's hand depending on the approach side.
  Terumo logo is positioned toward the little finger side.
  The green mark is positioned 1 cm proximal to the puncture site.
  The bands are adjusted and fixed around the wrist.
  The Terumo syringe is filled with 15 ml of air.
  The balloon of the device is slowly inflated through the valve while the introducer is slowly withdrawn simultaneously.
  Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified.
  Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon is inflated to achieve adequate hemostasis.
  arm group label: PreludeSYNC distal
  arm group type: Active Comparator
  description: A specific hemostatic device, designed for distal radial approach.
  Clean and dry the puncture site.
  Selection and preparation of the PreludeSYNC distal device according to the approach side.
  The introducer is withdrawn 2cm.
  The hemostasis device is placed on the patient's hand.
  Bands position: 1) little finger side; 2) thumb side; 3) between the thumb and the index finger.
  The circular mark of the balloon is positioned 1cm proximal to the puncture site.
  Bands are adjusted and fixed.
  The syringe is filled with 10 ml of air.
  The balloon of the device is slowly inflated while the introducer is slowly withdrawn simultaneously.
  Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified.
  Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon should be inflated to achieve adequate hemostasis.
  intervention type: Device
  intervention name: Hemostatic device for distal radial approach.
  description: Hemostasis after distal radial approach is done with one of two devices, one of them is designed specifically for the distal radial approach; the other is not but a modified technique with the last one could be helpful.
  arm group label: Modified Terumo Radial Band
  arm group label: PreludeSYNC distal
  other name: PreludeSYNC distal
  other name: Terumo Radial Band
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Mexico
  responsible party type: Principal Investigator
  investigator affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
  investigator full name: Arnoldo Enmanuel Loáisiga Sáenz
  investigator title: Interventional Cardiology
  mesh term: Hemostatics