<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/NCT03273218</url>
  </required_header>
  <id_info>
    <org_study_id>HospitalSR</org_study_id>
    <nct_id>NCT03273218</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers</brief_title>
  <acronym>TICKET</acronym>
  <official_title>Effectiveness of the Tiger Catheter as a Simple Multipurpuse Catheter in Transradial Coronariography: Randomized Comparerd to Judkins Catheters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marcelo Alberto OLIVA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Roque</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr)&#xD;
      catheters, in coronariography via the right transradial approach.&#xD;
&#xD;
      This was a prospective, randomized, study of paralled design. Consecutive patients with acute&#xD;
      coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful&#xD;
      cannulation of right artery and informed consent to either Tiger or Judkins catheters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      analyzed a total of 120 consective diagnostic coronary angioggraphy cases from the right&#xD;
      radial approach. Of these 60 cases were performed with single catheter (Tiger) and 60 cases&#xD;
      were performed with conventional catheters (Judkins). The patients of both group were overall&#xD;
      well balanced for gender, age, risk factors, height, weight and body surface area. Diagnostic&#xD;
      angiograms were successfully achieved in all cases via the radial approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">July 20, 2016</completion_date>
  <primary_completion_date type="Actual">July 20, 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Produce time for the coronary angiography</measure>
    <time_frame>Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)</time_frame>
    <description>Produce time (min) was defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exist of the las diagnostic catheter the sheath.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>Day 0 (corresponding to time point of produce)</time_frame>
    <description>Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast Volume used</measure>
    <time_frame>Day 0 (corresponding to time point of produce)</time_frame>
    <description>contrast volume used (ml) was defined as the contrast volume between groups used for completion of coronary angiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radial artery Spasm</measure>
    <time_frame>Day 0 (corresponding to time point of produce). The radial artery spasm was recorded like YES or NOT.(registry did by nurse from beginning to end of coronary angiography)</time_frame>
    <description>Radial artery Spasm was defined as the discomfort or pain in the arm, between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Tiger catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tiger simple multipurpose catheter compared to Judkins catheters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Judkins catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Judkins right and judkins left catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tiger catheter</intervention_name>
    <arm_group_label>Tiger catheter</arm_group_label>
    <other_name>Tiger</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Judkins catheter</intervention_name>
    <arm_group_label>Judkins catheter</arm_group_label>
    <other_name>judkins right</other_name>
    <other_name>judkins left</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  indication for coronary angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  negative Allen´s test&#xD;
&#xD;
          -  Chronic renal failure (to preserve the right radial artery for potencial arteriovenous&#xD;
             shunting)&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  coronary artery bypass grafting&#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>Marcelo OLIVA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital San Roque</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital San Roque</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Roque</investigator_affiliation>
    <investigator_full_name>Marcelo Alberto OLIVA</investigator_full_name>
    <investigator_title>interventional cardiologist</investigator_title>
  </responsible_party>
  <keyword>coronary angiography</keyword>
  <keyword>diagnosctic transradial catheter</keyword>
  <keyword>transradial catheter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03273218/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03273218
org study id: HospitalSR
nct id: NCT03273218
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr)
      catheters, in coronariography via the right transradial approach.

      This was a prospective, randomized, study of paralled design. Consecutive patients with acute
      coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful
      cannulation of right artery and informed consent to either Tiger or Judkins catheters.
analyzed a total of 120 consective diagnostic coronary angioggraphy cases from the right
      radial approach. Of these 60 cases were performed with single catheter (Tiger) and 60 cases
      were performed with conventional catheters (Judkins). The patients of both group were overall
      well balanced for gender, age, risk factors, height, weight and body surface area. Diagnostic
      angiograms were successfully achieved in all cases via the radial approach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Produce time for the coronary angiography
time frame: Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)
description: Produce time (min) was defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exist of the las diagnostic catheter the sheath.
measure: Fluoroscopy time
time frame: Day 0 (corresponding to time point of produce)
description: Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)
measure: Contrast Volume used
time frame: Day 0 (corresponding to time point of produce)
description: contrast volume used (ml) was defined as the contrast volume between groups used for completion of coronary angiogram
measure: Radial artery Spasm
time frame: Day 0 (corresponding to time point of produce). The radial artery spasm was recorded like YES or NOT.(registry did by nurse from beginning to end of coronary angiography)
description: Radial artery Spasm was defined as the discomfort or pain in the arm, between groups
arm group label: Tiger catheter
arm group type: Experimental
description: Tiger simple multipurpose catheter compared to Judkins catheters
arm group label: Judkins catheter
arm group type: Active Comparator
description: Judkins right and judkins left catheter
intervention type: Device
intervention name: Tiger catheter
arm group label: Tiger catheter
other name: Tiger
intervention type: Device
intervention name: Judkins catheter
arm group label: Judkins catheter
other name: judkins right
other name: judkins left
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcelo OLIVA, MD
role: Principal Investigator
affiliation: Hospital San Roque
facility: 
country: Argentina
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital San Roque
investigator full name: Marcelo Alberto OLIVA
investigator title: interventional cardiologist
mesh term: Acute Coronary Syndrome
sharing ipd: No
ipd description: The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.
provided document: 