<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/NCT03794687</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201802924</org_study_id>
    <nct_id>NCT03794687</nct_id>
  </id_info>
  <brief_title>The Distal (SnUffbox) Radial artERy Access for Coronary Angiography and Interventions (SUPER-Prospective)</brief_title>
  <official_title>The Distal (SnUffbox) Radial artERy Access for Coronary Angiography and Interventions (SUPER-Prospective)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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 study team aims to perform a prospective observational case series of one hundred&#xD;
      consecutive distal radial artery heart catheterizations to evaluate the safety and&#xD;
      feasibility of distal radial access. Distal radial artery access has evolved in the past few&#xD;
      years as an alternative to the standard radial artery access for coronary angiography and&#xD;
      interventions. However, the available data on the distal radial artery access for coronary&#xD;
      angiography and interventions is limited to case reports and small retrospective case series.&#xD;
      To date, no prospective randomized data is available. Therefore, the investigators aim to&#xD;
      perform a prospective observational case series of one hundred sequential left heart&#xD;
      catheterizations performed via distal radial artery to evaluate the safety and feasibility of&#xD;
      the distal radial artery access.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the abundance of data supporting the use of the radial artery compared to the femoral&#xD;
      artery, data on the use the distal radial access site in the anatomical snuffbox is limited.&#xD;
      Most of the available literature on the distal radial access comes from case reports and&#xD;
      small retrospective case series looking primarily at the feasibility and success rates with&#xD;
      this approach (4-6). Crossover rate from proximal radial to femoral approach in a prior&#xD;
      randomized controlled trial was reported at 3.7% (2). A similar rate has been reported in&#xD;
      case series studies of distal radial access, with success rates ranging from 88.6% to 96.3%&#xD;
      (4-6). No cases of radial artery occlusion, hematoma, or hand paresthesia were reported in&#xD;
      any of these series. Given the promising results with the distal radial approach, its use has&#xD;
      expanded to many cardiac catheterization laboratories across the country. However,&#xD;
      prospective randomized data comparing distal versus the conventional proximal radial arterial&#xD;
      access sites is warranted.&#xD;
&#xD;
      Therefore, the aim of this study is to compile a prospective observational case series to&#xD;
      evaluate the safety and feasibility of distal radial artery access in a prospective case&#xD;
      series. If an acceptable safety profile can be demonstrated, the case series will be followed&#xD;
      with a randomized controlled trial directly comparing distal to standard proximal radial&#xD;
      artery approach.&#xD;
&#xD;
      Specific Aims and study hypothesis:&#xD;
&#xD;
      The primary aim of the present study is to assess the safety and feasibility of distal radial&#xD;
      arterial access. The study hypothesis is that distal radial access for coronary angiography&#xD;
      is associated with similar incidence rates of access site related complications compared to&#xD;
      complication rates previously reported with the standard proximal radial artery access.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 3, 2019</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Safety of distal radial arterial access</measure>
    <time_frame>10 Minutes</time_frame>
    <description>Incidence of any radial access complication defined as the composite of radial artery occlusion, radial artery vasospasm, other access site related bleeding or vascular complications, or hand dysfunction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of distal radial arterial access defined as failure of access within 10 minutes with conversion to an alternative arterial access site.</measure>
    <time_frame>10 Minutes</time_frame>
    <description>Failure of access will be defined as inability to obtain access within 10 minutes from initial administration of local anesthetic to successful cannulation of the radial artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>30 Minutes</time_frame>
    <description>Patient satisfaction will be assessed with a patient satisfaction survey following the procedure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Coronary Angiography</condition>
  <arm_group>
    <arm_group_label>Distal Radial Artery</arm_group_label>
    <description>Left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left heart catheterization</intervention_name>
    <description>Catheterization via the distal radial artery</description>
    <arm_group_label>Distal Radial Artery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data of up to one hundred consecutive patients undergoing left heart catheterization via&#xD;
        the distal radial artery (dorsal aspect of the hand at the base of the thumb) will be&#xD;
        collected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo diagnostic left heart catheterization with or without&#xD;
             percutaneous coronary intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamically unstable (on vasopressor continuous infusion, on mechanical support)&#xD;
             patients.&#xD;
&#xD;
          -  Patients undergoing emergent left heart catheterization for ST-elevation myocardial&#xD;
             infarction.&#xD;
&#xD;
          -  Full oral anticoagulation defined as use of a direct oral anticoagulant (DOAC) within&#xD;
             24 hours or an INR over 2.0 the day of the procedure.&#xD;
&#xD;
          -  Active bleeding or known history of blood dyscrasia or bleeding diathesis.&#xD;
&#xD;
          -  History of ipsilateral arteriovenous fistula or vascular surgical intervention.&#xD;
&#xD;
          -  Patients unable to undergo distal radial artery access due to anatomical deformities,&#xD;
             limited mobility, or other.&#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>Andres Pineda Maldonado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Allen Brown, MD</last_name>
    <phone>904-244-5915</phone>
    <email>allen.brown@jax.ufl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andres Pineda Maldonado, MD</last_name>
    <phone>904-244-5915</phone>
    <email>Andres.PinedaMaldonado@jax.ufl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Left heart catheterizations</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/NCT03794687
org study id: IRB201802924
nct id: NCT03794687
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team aims to perform a prospective observational case series of one hundred
      consecutive distal radial artery heart catheterizations to evaluate the safety and
      feasibility of distal radial access. Distal radial artery access has evolved in the past few
      years as an alternative to the standard radial artery access for coronary angiography and
      interventions. However, the available data on the distal radial artery access for coronary
      angiography and interventions is limited to case reports and small retrospective case series.
      To date, no prospective randomized data is available. Therefore, the investigators aim to
      perform a prospective observational case series of one hundred sequential left heart
      catheterizations performed via distal radial artery to evaluate the safety and feasibility of
      the distal radial artery access.
Despite the abundance of data supporting the use of the radial artery compared to the femoral
      artery, data on the use the distal radial access site in the anatomical snuffbox is limited.
      Most of the available literature on the distal radial access comes from case reports and
      small retrospective case series looking primarily at the feasibility and success rates with
      this approach (4-6). Crossover rate from proximal radial to femoral approach in a prior
      randomized controlled trial was reported at 3.7% (2). A similar rate has been reported in
      case series studies of distal radial access, with success rates ranging from 88.6% to 96.3%
      (4-6). No cases of radial artery occlusion, hematoma, or hand paresthesia were reported in
      any of these series. Given the promising results with the distal radial approach, its use has
      expanded to many cardiac catheterization laboratories across the country. However,
      prospective randomized data comparing distal versus the conventional proximal radial arterial
      access sites is warranted.

      Therefore, the aim of this study is to compile a prospective observational case series to
      evaluate the safety and feasibility of distal radial artery access in a prospective case
      series. If an acceptable safety profile can be demonstrated, the case series will be followed
      with a randomized controlled trial directly comparing distal to standard proximal radial
      artery approach.

      Specific Aims and study hypothesis:

      The primary aim of the present study is to assess the safety and feasibility of distal radial
      arterial access. The study hypothesis is that distal radial access for coronary angiography
      is associated with similar incidence rates of access site related complications compared to
      complication rates previously reported with the standard proximal radial artery access.
observational model: Cohort
time perspective: Prospective
measure: Safety of distal radial arterial access
time frame: 10 Minutes
description: Incidence of any radial access complication defined as the composite of radial artery occlusion, radial artery vasospasm, other access site related bleeding or vascular complications, or hand dysfunction
measure: Feasibility of distal radial arterial access defined as failure of access within 10 minutes with conversion to an alternative arterial access site.
time frame: 10 Minutes
description: Failure of access will be defined as inability to obtain access within 10 minutes from initial administration of local anesthetic to successful cannulation of the radial artery.
measure: Patient satisfaction
time frame: 30 Minutes
description: Patient satisfaction will be assessed with a patient satisfaction survey following the procedure
arm group label: Distal Radial Artery
description: Left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb).
intervention type: Procedure
intervention name: Left heart catheterization
description: Catheterization via the distal radial artery
arm group label: Distal Radial Artery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andres Pineda Maldonado, MD
role: Principal Investigator
affiliation: University of Florida
last name: Allen Brown, MD
phone: 904-244-5915
email: allen.brown@jax.ufl.edu
last name: Andres Pineda Maldonado, MD
phone: 904-244-5915
email: Andres.PinedaMaldonado@jax.ufl.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor