<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/NCT02200783</url>
  </required_header>
  <id_info>
    <org_study_id>718016</org_study_id>
    <secondary_id>CAAE 32767514.0.0000.5413</secondary_id>
    <nct_id>NCT02200783</nct_id>
  </id_info>
  <brief_title>Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes</brief_title>
  <acronym>TRIPTABLE</acronym>
  <official_title>Randomized Comparison of Radiological Exposure Between Radial and Femoral Technique Assessing Use of Protective Device Dedicated TRIPTable® in Patients With Acute Coronary Syndromes Undergoing Cardiac Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marilia Medicine School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marilia Medicine School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Excessive radiation received by the operator has been described as a possible drawback of the&#xD;
      radial catheterization technique when compared with the femoral access.&#xD;
&#xD;
      The study hypothesis is that the use of radial access device dedicated radioprotective&#xD;
      TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral&#xD;
      technique and superior to standard radial technique as radioprotection strategy to the&#xD;
      operator in patients with acute coronary syndromes acute and submitted to cardiac&#xD;
      catheterization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and&#xD;
      radial radial technique with and without dedicated TRIPTable ® device.&#xD;
&#xD;
      The TripTable device is a polycarbonate support table anatomically-designed to facilitate the&#xD;
      radial technique, facilitating the puncturing, positioning, support to work material and&#xD;
      providing further radioprotection from a lead layer without obstruction in viewing the&#xD;
      fluoroscopic images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">July 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation dose</measure>
    <time_frame>1 year</time_frame>
    <description>Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation according measured site</measure>
    <time_frame>1 year</time_frame>
    <description>accumulated radiation dose received by each measured site (gonadal, thyroid and lens)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator absorbed radiation according total radiation dose</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluation of radiation dose to the operator according to linear correlation corrected for total dose of radiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of procedure</measure>
    <time_frame>1 year</time_frame>
    <description>Success rate of the procedure, as defined by perform the procedure without need to cross between techniques</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical data</measure>
    <time_frame>1 year</time_frame>
    <description>Registration of clinical features and procedural data, to compare with historical control group (ARISE trial - NCT01653587) using similar inclusion criteria without the objectives of the current study operator (to exclude Hawthorne effect).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">99</enrollment>
  <condition>Acute Coronary Syndromes</condition>
  <condition>Angioplasty, Transluminal, Percutaneous Coronary</condition>
  <arm_group>
    <arm_group_label>Radial</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cardiac catheterization and coronary angioplasty performed via standard radial artery technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Femoral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TripTable</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TripTable</intervention_name>
    <description>Details of the device previously described, designed to medical operator radioprotection. No changes in radial technique beyond the use of the supportive device will be performed.</description>
    <arm_group_label>TripTable</arm_group_label>
    <other_name>TRansradial Intervention Protection Table</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Radial</intervention_name>
    <description>Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.</description>
    <arm_group_label>Radial</arm_group_label>
    <other_name>PHILIPS standard cath arm support - NCVA097</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Femoral</intervention_name>
    <description>Standard femoral artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary. The supporting device will be the patient's own body, placing the material above the legs.</description>
    <arm_group_label>Femoral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unstable angina with an indication for invasive stratification&#xD;
&#xD;
          -  Acute coronary syndrome without ST-segment elevation&#xD;
&#xD;
          -  Acute coronary syndrome with ST-segment elevation&#xD;
&#xD;
          -  Patient informed of the nature of the study and have signed the Informed Consent&#xD;
&#xD;
          -  Patient suitable for coronary angiography and / or percutaneous coronary intervention&#xD;
             either by radial access as the femoral&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below 18 years of age&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of&#xD;
             factor Xa,&#xD;
&#xD;
          -  Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic&#xD;
             ulcer disease, creatinine clearance &lt;30 mL / min, platelet count &lt;100,000 mm3);&#xD;
&#xD;
          -  Uncontrolled hypertension;&#xD;
&#xD;
          -  Cardiogenic shock;&#xD;
&#xD;
          -  Previous coronary artery bypass graft surgery with the use of ≥ 1 graft&#xD;
&#xD;
          -  Patients not candidates for the use of any of the specified vascular access&#xD;
&#xD;
          -  Concomitant severe disease with life expectancy less than 12 months life;&#xD;
&#xD;
          -  Medical, geographical, or social conditions that impede study participation&#xD;
&#xD;
          -  Refusal or inability to understand and sign the informed consent form.&#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>Igor RC Bienert, MD</last_name>
    <role>Study Director</role>
    <affiliation>Marilia School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marilia School of Medicine</name>
      <address>
        <city>Marilia</city>
        <state>SP</state>
        <zip>17514410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Chambers CE, Fetterly KA, Holzer R, Lin PJ, Blankenship JC, Balter S, Laskey WK. Radiation safety program for the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):546-56. doi: 10.1002/ccd.22867. Epub 2011 Jan 19.</citation>
    <PMID>21254324</PMID>
  </reference>
  <reference>
    <citation>Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.</citation>
    <PMID>21586692</PMID>
  </reference>
  <reference>
    <citation>Sciahbasi A, Calabro P, Sarandrea A, Rigattieri S, Tomassini F, Sardella G, Zavalloni D, Cortese B, Limbruno U, Tebaldi M, Gagnor A, Rubartelli P, Zingarelli A, Valgimigli M. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX). Cardiovasc Revasc Med. 2014 Jun;15(4):209-13. doi: 10.1016/j.carrev.2014.03.010. Epub 2014 Mar 26.</citation>
    <PMID>24746599</PMID>
  </reference>
  <reference>
    <citation>Park EY, Shroff AR, Crisco LV, Vidovich MI. A review of radiation exposures associated with radial cardiac catheterisation. EuroIntervention. 2013 Oct;9(6):745-53. doi: 10.4244/EIJV9I6A119.</citation>
    <PMID>24169135</PMID>
  </reference>
  <results_reference>
    <citation>de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, Franca JI, de Andrade MV, Barbosa RA, Labrunie A, Abizaid AA, Sousa AG. Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients. Trials. 2013 Dec 18;14:435. doi: 10.1186/1745-6215-14-435.</citation>
    <PMID>24345099</PMID>
  </results_reference>
  <results_reference>
    <citation>Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4. Erratum In: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30.</citation>
    <PMID>21470671</PMID>
  </results_reference>
  <results_reference>
    <citation>Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.</citation>
    <PMID>22858390</PMID>
  </results_reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 21, 2015</last_update_submitted>
  <last_update_submitted_qc>July 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Marilia Medicine School</investigator_affiliation>
    <investigator_full_name>Igor Bienert</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Cardiac catheterization</keyword>
  <keyword>Radiation Protection</keyword>
  <keyword>Radial artery</keyword>
  <keyword>Femoral artery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02200783
org study id: 718016
secondary id: CAAE 32767514.0.0000.5413
nct id: NCT02200783
lead sponsor: 
has dmc: No
Excessive radiation received by the operator has been described as a possible drawback of the
      radial catheterization technique when compared with the femoral access.

      The study hypothesis is that the use of radial access device dedicated radioprotective
      TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral
      technique and superior to standard radial technique as radioprotection strategy to the
      operator in patients with acute coronary syndromes acute and submitted to cardiac
      catheterization.
This study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and
      radial radial technique with and without dedicated TRIPTable ® device.

      The TripTable device is a polycarbonate support table anatomically-designed to facilitate the
      radial technique, facilitating the puncturing, positioning, support to work material and
      providing further radioprotection from a lead layer without obstruction in viewing the
      fluoroscopic images.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radiation dose
time frame: 1 year
description: Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)
measure: Radiation according measured site
time frame: 1 year
description: accumulated radiation dose received by each measured site (gonadal, thyroid and lens)
measure: Operator absorbed radiation according total radiation dose
time frame: 1 year
description: Evaluation of radiation dose to the operator according to linear correlation corrected for total dose of radiation.
measure: Success of procedure
time frame: 1 year
description: Success rate of the procedure, as defined by perform the procedure without need to cross between techniques
measure: Clinical data
time frame: 1 year
description: Registration of clinical features and procedural data, to compare with historical control group (ARISE trial - NCT01653587) using similar inclusion criteria without the objectives of the current study operator (to exclude Hawthorne effect).
arm group label: Radial
arm group type: Active Comparator
description: Cardiac catheterization and coronary angioplasty performed via standard radial artery technique.
arm group label: Femoral
arm group type: Active Comparator
description: Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique.
arm group label: TripTable
arm group type: Experimental
description: Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device.
intervention type: Device
intervention name: TripTable
description: Details of the device previously described, designed to medical operator radioprotection. No changes in radial technique beyond the use of the supportive device will be performed.
arm group label: TripTable
other name: TRansradial Intervention Protection Table
intervention type: Device
intervention name: Radial
description: Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.
arm group label: Radial
other name: PHILIPS standard cath arm support - NCVA097
intervention type: Device
intervention name: Femoral
description: Standard femoral artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary. The supporting device will be the patient's own body, placing the material above the legs.
arm group label: Femoral
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Igor RC Bienert, MD
role: Study Director
affiliation: Marilia School of Medicine
facility: 
country: Brazil
citation: Chambers CE, Fetterly KA, Holzer R, Lin PJ, Blankenship JC, Balter S, Laskey WK. Radiation safety program for the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):546-56. doi: 10.1002/ccd.22867. Epub 2011 Jan 19.
PMID: 21254324
citation: Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.
PMID: 21586692
citation: Sciahbasi A, Calabro P, Sarandrea A, Rigattieri S, Tomassini F, Sardella G, Zavalloni D, Cortese B, Limbruno U, Tebaldi M, Gagnor A, Rubartelli P, Zingarelli A, Valgimigli M. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX). Cardiovasc Revasc Med. 2014 Jun;15(4):209-13. doi: 10.1016/j.carrev.2014.03.010. Epub 2014 Mar 26.
PMID: 24746599
citation: Park EY, Shroff AR, Crisco LV, Vidovich MI. A review of radiation exposures associated with radial cardiac catheterisation. EuroIntervention. 2013 Oct;9(6):745-53. doi: 10.4244/EIJV9I6A119.
PMID: 24169135
citation: de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, Franca JI, de Andrade MV, Barbosa RA, Labrunie A, Abizaid AA, Sousa AG. Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients. Trials. 2013 Dec 18;14:435. doi: 10.1186/1745-6215-14-435.
PMID: 24345099
citation: Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4. Erratum In: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30.
PMID: 21470671
citation: Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.
PMID: 22858390
responsible party type: Principal Investigator
investigator affiliation: Marilia Medicine School
investigator full name: Igor Bienert
investigator title: MD
mesh term: Acute Coronary Syndrome
mesh term: Syndrome