<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/NCT01677481</url>
  </required_header>
  <id_info>
    <org_study_id>MIL/IMRC/RP/TP/10/2010</org_study_id>
    <nct_id>NCT01677481</nct_id>
  </id_info>
  <brief_title>Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial</brief_title>
  <acronym>REVERE</acronym>
  <official_title>Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Total Cardiovascular Solutions</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Total Cardiovascular Solutions</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study compares radiation exposure parameters between coronary angiography procedures&#xD;
      performed by left wrist, right wrist or groin (femoral) procedure access site&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients referred for coronary angiography will be randomized to either left radial, right&#xD;
      radial or femoral arterial access sites, and the coronary angiogram will be performed in a&#xD;
      standard fashion, including left ventriculography. Radiation exposure parameters including&#xD;
      Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be&#xD;
      recorded. Operator experience as well as demographic data will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Air Kerma</measure>
    <time_frame>1 day</time_frame>
    <description>The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Operator radiation exposure</measure>
    <time_frame>1 day</time_frame>
    <description>operator radiation exposure will be measured by a personal dosimeter worn by the operator outside the lead apron on the vest pocket.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1500</enrollment>
  <condition>Exposure to Ionizing Radiation</condition>
  <arm_group>
    <arm_group_label>Femoral</arm_group_label>
    <description>Coronary angiography procedures performed using transfemoral access</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left radial access</arm_group_label>
    <description>Coronary angiography procedures performed using left radial access site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right radial Access</arm_group_label>
    <description>Coronary angiography procedures performed using Right radial access site.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred for diagnostic coronary angiography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing diagnostic coronary angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-availability of one or more of the three access sites History of coronary artery&#xD;
             bypass graft surgery Need for percutaneous coronary intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tejas M Patel, MD, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>V.S. General Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>March 11, 2016</last_update_submitted>
  <last_update_submitted_qc>March 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01677481
org study id: MIL/IMRC/RP/TP/10/2010
nct id: NCT01677481
lead sponsor: 
has dmc: No
The study compares radiation exposure parameters between coronary angiography procedures
      performed by left wrist, right wrist or groin (femoral) procedure access site
Patients referred for coronary angiography will be randomized to either left radial, right
      radial or femoral arterial access sites, and the coronary angiogram will be performed in a
      standard fashion, including left ventriculography. Radiation exposure parameters including
      Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be
      recorded. Operator experience as well as demographic data will be recorded.
observational model: Cohort
time perspective: Prospective
measure: Air Kerma
time frame: 1 day
description: The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.
measure: Operator radiation exposure
time frame: 1 day
description: operator radiation exposure will be measured by a personal dosimeter worn by the operator outside the lead apron on the vest pocket.
arm group label: Femoral
description: Coronary angiography procedures performed using transfemoral access
arm group label: Left radial access
description: Coronary angiography procedures performed using left radial access site.
arm group label: Right radial Access
description: Coronary angiography procedures performed using Right radial access site.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Tejas M Patel, MD, DM
role: Principal Investigator
affiliation: Chief
facility: 
country: India
responsible party type: Sponsor
sharing ipd: No