<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/NCT03259126</url>
  </required_header>
  <id_info>
    <org_study_id>Pertini05</org_study_id>
    <nct_id>NCT03259126</nct_id>
  </id_info>
  <brief_title>EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures</brief_title>
  <acronym>EXTRA-RAD</acronym>
  <official_title>Evaluation of a New Device Placed Under the Angiographic Table to Reduce Operator Radiation Exposure During Percutaneous Coronary Procedures Through Transradial Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale Sandro Pertini, Roma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale Sandro Pertini, Roma</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>
      Radiation dose to interventional cardiologists performing transradial percutaneous coronary&#xD;
      procedures is higher compared to those performing transfemoral exams. The radiation dose&#xD;
      seems particularly high at pelvic level. We prepared an home-made protective extension of the&#xD;
      leaded curtain under table that should reduce the operator exposure during interventional&#xD;
      coronary procedures. The aim of the study is to evaluate the procedural efficacy of the&#xD;
      protective extension on the operator radiation dose at pelvic level&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventional cardiologists are routinely exposed to x-rays during their activity increasing&#xD;
      the risk of deterministic and stochastic effects. Consequently all the operators should be&#xD;
      aware of the possible risks and they should apply all efforts to reduce the radiation dose&#xD;
      according to the &quot;As Low As Reasonably Achievable&quot; (ALARA) principle. Moreover interventional&#xD;
      cardiologists have to utilise adequate protection devices (lead apron, protective thyroid&#xD;
      collar, lead glasses).&#xD;
&#xD;
      Operator performing transradial access procedures showed a significantly higher radiation&#xD;
      exposure compared to those performing transfemoral interventions. So, transradial operators&#xD;
      should use adjunctive protective shields (as leaded pelvic drapes placed on the patient&#xD;
      abdomen) in order to reduce their radio-exposition.&#xD;
&#xD;
      During transradial access a particularly high radiation exposure is observed at operator&#xD;
      pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is&#xD;
      only partially effective to control this exposition.&#xD;
&#xD;
      Aim of our study was to evaluate the effect of a protective extension of the leaded curtain&#xD;
      placed under the angiographic table in term of operator radiation exposure at pelvic level&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">August 13, 2018</completion_date>
  <primary_completion_date type="Actual">August 13, 2018</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>
    <intervention_model_description>Comparison of operator radiation dose at pelvic level during percutaneous coronary procedures through transradial access with or without an extension of the leaded curtain under table</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operator pelvic dose</measure>
    <time_frame>24 hours</time_frame>
    <description>Operator radiation dose at pelvic level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operator thorax dose</measure>
    <time_frame>24 hours</time_frame>
    <description>Operator radiation dose at thorax level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator head dose</measure>
    <time_frame>24 hours</time_frame>
    <description>Operator radiation dose at head level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator pelvic dose and experimental curtain utilized</measure>
    <time_frame>24 hours</time_frame>
    <description>Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Radiation</condition>
  <condition>X-rays; Effects</condition>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>SCUT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of a &quot;Small Curtain under table&quot; (SCUT) placed under the cranial part of the angiographic table</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group without the SCUT</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SCUT</intervention_name>
    <description>Two different home made curtains were attached to the angiographic table</description>
    <arm_group_label>SCUT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        all patient undergoing percutaneous coronary procedures through transradial access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Interventions performed through a different vascular access&#xD;
&#xD;
          2. Procedures performed in patients with ST elevation acute myocardial infarction&#xD;
&#xD;
          3. Haemodynamic instability&#xD;
&#xD;
          4. Lack of written informed consent&#xD;
&#xD;
          5. Age &lt; 18 years old&#xD;
&#xD;
          6. Previous coronary artery by-pass&#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>Alessandro Sciahbasi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospeadale Sandro Pertini ASL RM2</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedale Sandro Pertini</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 17, 2018</last_update_submitted>
  <last_update_submitted_qc>August 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale Sandro Pertini, Roma</investigator_affiliation>
    <investigator_full_name>Alessandro Sciahbasi, MD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Transradial</keyword>
  <keyword>Coronary</keyword>
  <keyword>X-ray</keyword>
  <keyword>Radiation</keyword>
  <keyword>Curtain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
  </condition_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/NCT03259126
org study id: Pertini05
nct id: NCT03259126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Radiation dose to interventional cardiologists performing transradial percutaneous coronary
      procedures is higher compared to those performing transfemoral exams. The radiation dose
      seems particularly high at pelvic level. We prepared an home-made protective extension of the
      leaded curtain under table that should reduce the operator exposure during interventional
      coronary procedures. The aim of the study is to evaluate the procedural efficacy of the
      protective extension on the operator radiation dose at pelvic level
Interventional cardiologists are routinely exposed to x-rays during their activity increasing
      the risk of deterministic and stochastic effects. Consequently all the operators should be
      aware of the possible risks and they should apply all efforts to reduce the radiation dose
      according to the "As Low As Reasonably Achievable" (ALARA) principle. Moreover interventional
      cardiologists have to utilise adequate protection devices (lead apron, protective thyroid
      collar, lead glasses).

      Operator performing transradial access procedures showed a significantly higher radiation
      exposure compared to those performing transfemoral interventions. So, transradial operators
      should use adjunctive protective shields (as leaded pelvic drapes placed on the patient
      abdomen) in order to reduce their radio-exposition.

      During transradial access a particularly high radiation exposure is observed at operator
      pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is
      only partially effective to control this exposition.

      Aim of our study was to evaluate the effect of a protective extension of the leaded curtain
      placed under the angiographic table in term of operator radiation exposure at pelvic level
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparison of operator radiation dose at pelvic level during percutaneous coronary procedures through transradial access with or without an extension of the leaded curtain under table
primary purpose: Treatment
masking: None (Open Label)
measure: Operator pelvic dose
time frame: 24 hours
description: Operator radiation dose at pelvic level
measure: Operator thorax dose
time frame: 24 hours
description: Operator radiation dose at thorax level
measure: Operator head dose
time frame: 24 hours
description: Operator radiation dose at head level
measure: Operator pelvic dose and experimental curtain utilized
time frame: 24 hours
description: Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized
arm group label: SCUT
arm group type: Experimental
description: Use of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table
arm group label: Control
arm group type: No Intervention
description: Control Group without the SCUT
intervention type: Device
intervention name: SCUT
description: Two different home made curtains were attached to the angiographic table
arm group label: SCUT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Sciahbasi, MD, PhD
role: Principal Investigator
affiliation: Ospeadale Sandro Pertini ASL RM2
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Ospedale Sandro Pertini, Roma
investigator full name: Alessandro Sciahbasi, MD
investigator title: MD, PhD
mesh term: Coronary Disease
sharing ipd: No