<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/NCT01707524</url>
  </required_header>
  <id_info>
    <org_study_id>S12-02885</org_study_id>
    <nct_id>NCT01707524</nct_id>
  </id_info>
  <brief_title>Left Versus Right Radial Artery and Radiation Exposure in Patients With Predictors of Trans-radial Failure</brief_title>
  <official_title>Effect of Left Versus Right Radial Artery Access on Radiation Exposure in Patients With Predictors of Potential Trans-radial Access Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <brief_summary>
    <textblock>
      The aim of this study is to measure radiation exposure during coronary angiography (CA) with&#xD;
      a trans-radial approach (TRA), specifically comparing access via the left versus right radial&#xD;
      artery in patients with suggested clinical predictors of TRA failure/difficult. These&#xD;
      predictors include age &gt;70, female gender, height &lt;64 inches, and history of hypertension.The&#xD;
      study also aims to determine difficulties encountered during left or right radial access in&#xD;
      this specific patient population. A secondary aim is to compare the results of enrolled&#xD;
      patients with a registry of patients where femoral access was obtained.&#xD;
&#xD;
      Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the&#xD;
      United States annually. There is a growing trend to perform procedures utilizing the TRA due&#xD;
      to recent data demonstrating decreased bleeding and access-site complications compared to the&#xD;
      femoral approach. However, the TRA approach is also know to be associated with greater&#xD;
      radiation exposure compared to the femoral approach. Furthermore, the TRA to catheterization&#xD;
      may be difficult in certain populations because of anatomic considerations. Though&#xD;
      traditionally completed via canalization of the right radial artery (RRA) due to feasibility&#xD;
      with room setup, left radial artery (LRA) access may be superior due to the shorter distance&#xD;
      needed to reach the ascending aorta and bypassing the tortuosity of the right subclavian&#xD;
      artery. Given the benefits of the TRA, it is important to determine how left versus right&#xD;
      radial artery access affects parameters of radiation exposure in addition to procedural&#xD;
      difficulty.&#xD;
&#xD;
      This study will be a prospective, randomized study of patients with suggested predictors of&#xD;
      TRA failure/difficulty referred for coronary angiography. Patients referred for coronary&#xD;
      angiography using the trans-radial approach will be randomly assigned to obtain arterial&#xD;
      access via the right or left radial artery. A registry of patients referred for coronary&#xD;
      angiography using the trans-femoral approach will be compiled. The primary outcome measure&#xD;
      will be radiation exposure as measured by dose area product output from the coronary&#xD;
      angiography system. Secondary measures will include the total fluoroscopy time, total dose of&#xD;
      radiation, number of catheters used, and incidence of subclavian tortuosity. In addition,&#xD;
      procedural complications and success rates will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">May 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose area product</measure>
    <time_frame>During coronary angiography</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>total fluoroscopy time</measure>
    <time_frame>during coronary angiography and PCI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total radiation dose</measure>
    <time_frame>during coronary angiography and PCI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of catheters used</measure>
    <time_frame>during coronary angiography</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of subclavian tortuosity</measure>
    <time_frame>during coronary angiography</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Trans-radial approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized left versus right radial artery approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trans-femoral approach</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Observational</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Randomized left versus right radial artery approach</intervention_name>
    <description>Randomized left versus right radial artery approach</description>
    <arm_group_label>Trans-radial approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients referred for cardiac catheterization procedure with 3 out of the following 4&#xD;
        characteristics: age ≥70 years, female gender, hypertensive, and ≤64 inches in height.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they 1) underwent prior CABG with utilization of an internal&#xD;
        mammary artery, 2) have an abnormal Allen test, 3) require emergency cardiac&#xD;
        catheterization, 4) are planned to undergo a staged PCI procedure, 5) do not consent or are&#xD;
        unable to give consent, or 6) are participating in another competing study.&#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>John Coppola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Binita Shah, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NYU Langone Health</investigator_affiliation>
    <investigator_full_name>John Coppola</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01707524
org study id: S12-02885
nct id: NCT01707524
lead sponsor: 
The aim of this study is to measure radiation exposure during coronary angiography (CA) with
      a trans-radial approach (TRA), specifically comparing access via the left versus right radial
      artery in patients with suggested clinical predictors of TRA failure/difficult. These
      predictors include age >70, female gender, height <64 inches, and history of hypertension.The
      study also aims to determine difficulties encountered during left or right radial access in
      this specific patient population. A secondary aim is to compare the results of enrolled
      patients with a registry of patients where femoral access was obtained.

      Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the
      United States annually. There is a growing trend to perform procedures utilizing the TRA due
      to recent data demonstrating decreased bleeding and access-site complications compared to the
      femoral approach. However, the TRA approach is also know to be associated with greater
      radiation exposure compared to the femoral approach. Furthermore, the TRA to catheterization
      may be difficult in certain populations because of anatomic considerations. Though
      traditionally completed via canalization of the right radial artery (RRA) due to feasibility
      with room setup, left radial artery (LRA) access may be superior due to the shorter distance
      needed to reach the ascending aorta and bypassing the tortuosity of the right subclavian
      artery. Given the benefits of the TRA, it is important to determine how left versus right
      radial artery access affects parameters of radiation exposure in addition to procedural
      difficulty.

      This study will be a prospective, randomized study of patients with suggested predictors of
      TRA failure/difficulty referred for coronary angiography. Patients referred for coronary
      angiography using the trans-radial approach will be randomly assigned to obtain arterial
      access via the right or left radial artery. A registry of patients referred for coronary
      angiography using the trans-femoral approach will be compiled. The primary outcome measure
      will be radiation exposure as measured by dose area product output from the coronary
      angiography system. Secondary measures will include the total fluoroscopy time, total dose of
      radiation, number of catheters used, and incidence of subclavian tortuosity. In addition,
      procedural complications and success rates will also be evaluated.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose area product
time frame: During coronary angiography
measure: total fluoroscopy time
time frame: during coronary angiography and PCI
measure: total radiation dose
time frame: during coronary angiography and PCI
measure: number of catheters used
time frame: during coronary angiography
measure: incidence of subclavian tortuosity
time frame: during coronary angiography
arm group label: Trans-radial approach
arm group type: Experimental
description: Randomized left versus right radial artery approach
arm group label: Trans-femoral approach
arm group type: No Intervention
description: Observational
intervention type: Procedure
intervention name: Randomized left versus right radial artery approach
description: Randomized left versus right radial artery approach
arm group label: Trans-radial approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Coppola, MD
role: Principal Investigator
affiliation: NYU Langone Health
last name: Binita Shah, MD, MS
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: NYU Langone Health
investigator full name: John Coppola
investigator title: Assistant Professor of Medicine
mesh term: Coronary Artery Disease