<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/NCT03042845</url>
  </required_header>
  <id_info>
    <org_study_id>PUH1</org_study_id>
    <nct_id>NCT03042845</nct_id>
  </id_info>
  <brief_title>Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study</brief_title>
  <acronym>JUDGE</acronym>
  <official_title>Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of Patras</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of Patras</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 investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional&#xD;
      Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary&#xD;
      angiography via the right transradial route. This is a prospective, randomized, two-centre,&#xD;
      study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible&#xD;
      for non-urgent coronary angiography, are randomized after successful cannulation of right&#xD;
      radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From the entrance of the first diagnostic catheter into the sheath and until the completion&#xD;
      of the diagnostic coronary angiography will be the measurement of the endpoints of the study.&#xD;
&#xD;
      In case of failure to complete the coronary angiogram with the catheter study a crossover to&#xD;
      the other catheter of the study will take place except in cases of severe spasm, where&#xD;
      catheter choice will be at the discretion of the operator. In case of failure of the other&#xD;
      study's catheter, next catheter's selection will be at operator's discretion. Patients&#xD;
      included in the study, who do not process to adhoc PCI, will be monitored with baseline&#xD;
      creatinine and creatinine value at day 2 or 3 after coronary angiography.&#xD;
&#xD;
      In all angiography films will be conducted offline analysis by two experienced operators for&#xD;
      scoring opacification grade and coronary ostium contact with the catheters used.&#xD;
&#xD;
      DEFINITIONS Mild spasm Spasm causing well tolerated local pain Moderate spasm Spasm which&#xD;
      causes severe pain but the handling of catheters remains satisfactory Severe spasm Spasm that&#xD;
      leads to change diagnostic catheter or access site Duration of coronary angiogram Is defined&#xD;
      as the time from the insertion of the first diagnostic coronary catheter in the sheath to the&#xD;
      exit of the last diagnostic catheter from the sheath Radiation time Radiation time from the&#xD;
      insertion of the first diagnostic coronary catheter in the right radial sheath to the exit of&#xD;
      the last diagnostic catheter from the sheath Dose area product (DAP) DAP from the insertion&#xD;
      of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic&#xD;
      catheter from the sheath Contrast volume Contrast volume (ml) used from the insertion of the&#xD;
      first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter&#xD;
      from the sheath Contrast induced nephropathy (CIN) Relative increase ≥25% from baseline or&#xD;
      absolute increase ≥ 0.5mg/dl of serum creatinine within 48-72 hours of intravenous contrast&#xD;
      administration Opacification grade 0=poor/non-diagnostic&#xD;
&#xD;
        1. moderate opacification only in systole or diastole&#xD;
&#xD;
        2. moderate opacification throughout cardiac cycle&#xD;
&#xD;
        3. complete opacification but not throughout cardiac cycle&#xD;
&#xD;
        4. complete opacification throughout cardiac cycle Catheter contact with coronary ostium&#xD;
&#xD;
      0=none and non-diagnostic study&#xD;
&#xD;
      1=none but diagnostic study 2=non-coaxial contact 3=coaxial contact Catheter stability within&#xD;
      the coronary ostium 0=no catheter's steady engagement of the ostium throughout the&#xD;
      angiographic view&#xD;
&#xD;
      1=catheter's steady engagement of the ostium throughout the angiographic view Catheter&#xD;
      failure Completion of coronary angiogram after study catheter crossover with or without right&#xD;
      radial access site crossover Based on pilot data and previously published data we&#xD;
      hypothesized that Tiger catheter use will lead to an absolute decrease of at least 5 ml in&#xD;
      contrast volume compared with Judkins catheters (48 and 53 ml for Tiger και Judkins catheters&#xD;
      respectively, with estimated standard deviation of 17 for both). With a 2-sided alpha of&#xD;
      0.05, group sample sizes of 316 and 316 will achieve 95% power to detect this difference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">May 25, 2017</completion_date>
  <primary_completion_date type="Actual">May 25, 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contrast volume</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contrast volume</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Contrast volume (in ml) between groups used for completion of coronary angiogram in per protocol analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Area Product (DAP)</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>DAP (cGy*cm2) between groups in intention to treat and per protocol analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Fluoroscopy time (min) between groups in ITT and per protocol analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast induced nephropathy (CIN)</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>CIN rate between groups in ITT and per protocol analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter failure</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Catheter failure rate between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe spasm</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Severe spasm rate between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary angiogram time</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Duration of coronary angiogram between groups in ITT and per protocol analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opacification grade</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Opacification grade for LAD, LCX and RCA between study catheters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contact to coronary ostium</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Contact to left and right coronary ostium between study catheters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stability within the coronary ostium</measure>
    <time_frame>End of coronary angiography</time_frame>
    <description>Catheter's steady engagement of the ostium throughout the angiographic view</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">640</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Judkins L3.5/R4 cardiac catheters</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tiger cardiac catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tiger cardiac catheter</intervention_name>
    <description>Tiger cardiac catheter</description>
    <arm_group_label>Tiger cardiac catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Judkins 3.5L/4R cardiac catheters</intervention_name>
    <description>Judkins 3.5L/4R cardiac catheters</description>
    <arm_group_label>Judkins L3.5/R4 cardiac catheters</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent&#xD;
&#xD;
          2. Indication for non-urgent coronary angiography&#xD;
&#xD;
          3. Successful cannulation of right radial artery&#xD;
&#xD;
          4. Availability of both Tiger and JL3.5/JR4 catheters&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Indication for urgent coronary angiography (ST-elevation myocardial infarction or non&#xD;
             ST-elevation myocardial infarction with indication for coronary angiogram within 2&#xD;
             hours)&#xD;
&#xD;
          2. Hemodynamic instability&#xD;
&#xD;
          3. Non palpable right coronary artery&#xD;
&#xD;
          4. Abnormal Allen test&#xD;
&#xD;
          5. Prior coronary artery bypass grafting&#xD;
&#xD;
          6. Chronic kidney disease or dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Patras University Hospital</name>
      <address>
        <city>Patras</city>
        <state>Achaia</state>
        <zip>26500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Department of Cardiology, Red Cross General Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>May 25, 2017</last_update_submitted>
  <last_update_submitted_qc>May 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of Patras</investigator_affiliation>
    <investigator_full_name>Xanthopoulou Ioanna</investigator_full_name>
    <investigator_title>Cardiologist</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03042845
org study id: PUH1
nct id: NCT03042845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional
      Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary
      angiography via the right transradial route. This is a prospective, randomized, two-centre,
      study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible
      for non-urgent coronary angiography, are randomized after successful cannulation of right
      radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.
From the entrance of the first diagnostic catheter into the sheath and until the completion
      of the diagnostic coronary angiography will be the measurement of the endpoints of the study.

      In case of failure to complete the coronary angiogram with the catheter study a crossover to
      the other catheter of the study will take place except in cases of severe spasm, where
      catheter choice will be at the discretion of the operator. In case of failure of the other
      study's catheter, next catheter's selection will be at operator's discretion. Patients
      included in the study, who do not process to adhoc PCI, will be monitored with baseline
      creatinine and creatinine value at day 2 or 3 after coronary angiography.

      In all angiography films will be conducted offline analysis by two experienced operators for
      scoring opacification grade and coronary ostium contact with the catheters used.

      DEFINITIONS Mild spasm Spasm causing well tolerated local pain Moderate spasm Spasm which
      causes severe pain but the handling of catheters remains satisfactory Severe spasm Spasm that
      leads to change diagnostic catheter or access site Duration of coronary angiogram Is defined
      as the time from the insertion of the first diagnostic coronary catheter in the sheath to the
      exit of the last diagnostic catheter from the sheath Radiation time Radiation time from the
      insertion of the first diagnostic coronary catheter in the right radial sheath to the exit of
      the last diagnostic catheter from the sheath Dose area product (DAP) DAP from the insertion
      of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic
      catheter from the sheath Contrast volume Contrast volume (ml) used from the insertion of the
      first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter
      from the sheath Contrast induced nephropathy (CIN) Relative increase ≥25% from baseline or
      absolute increase ≥ 0.5mg/dl of serum creatinine within 48-72 hours of intravenous contrast
      administration Opacification grade 0=poor/non-diagnostic

        1. moderate opacification only in systole or diastole

        2. moderate opacification throughout cardiac cycle

        3. complete opacification but not throughout cardiac cycle

        4. complete opacification throughout cardiac cycle Catheter contact with coronary ostium

      0=none and non-diagnostic study

      1=none but diagnostic study 2=non-coaxial contact 3=coaxial contact Catheter stability within
      the coronary ostium 0=no catheter's steady engagement of the ostium throughout the
      angiographic view

      1=catheter's steady engagement of the ostium throughout the angiographic view Catheter
      failure Completion of coronary angiogram after study catheter crossover with or without right
      radial access site crossover Based on pilot data and previously published data we
      hypothesized that Tiger catheter use will lead to an absolute decrease of at least 5 ml in
      contrast volume compared with Judkins catheters (48 and 53 ml for Tiger και Judkins catheters
      respectively, with estimated standard deviation of 17 for both). With a 2-sided alpha of
      0.05, group sample sizes of 316 and 316 will achieve 95% power to detect this difference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Contrast volume
time frame: End of coronary angiography
description: Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis
measure: Contrast volume
time frame: End of coronary angiography
description: Contrast volume (in ml) between groups used for completion of coronary angiogram in per protocol analysis
measure: Dose Area Product (DAP)
time frame: End of coronary angiography
description: DAP (cGy*cm2) between groups in intention to treat and per protocol analysis
measure: Fluoroscopy time
time frame: End of coronary angiography
description: Fluoroscopy time (min) between groups in ITT and per protocol analysis
measure: Contrast induced nephropathy (CIN)
time frame: End of coronary angiography
description: CIN rate between groups in ITT and per protocol analysis
measure: Catheter failure
time frame: End of coronary angiography
description: Catheter failure rate between groups
measure: Severe spasm
time frame: End of coronary angiography
description: Severe spasm rate between groups
measure: Coronary angiogram time
time frame: End of coronary angiography
description: Duration of coronary angiogram between groups in ITT and per protocol analysis
measure: Opacification grade
time frame: End of coronary angiography
description: Opacification grade for LAD, LCX and RCA between study catheters
measure: Contact to coronary ostium
time frame: End of coronary angiography
description: Contact to left and right coronary ostium between study catheters
measure: Stability within the coronary ostium
time frame: End of coronary angiography
description: Catheter's steady engagement of the ostium throughout the angiographic view
arm group label: Judkins L3.5/R4 cardiac catheters
arm group type: Active Comparator
arm group label: Tiger cardiac catheter
arm group type: Experimental
intervention type: Device
intervention name: Tiger cardiac catheter
description: Tiger cardiac catheter
arm group label: Tiger cardiac catheter
intervention type: Device
intervention name: Judkins 3.5L/4R cardiac catheters
description: Judkins 3.5L/4R cardiac catheters
arm group label: Judkins L3.5/R4 cardiac catheters
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University Hospital of Patras
investigator full name: Xanthopoulou Ioanna
investigator title: Cardiologist
mesh term: Coronary Artery Disease
sharing ipd: Undecided