<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/NCT04459299</url>
  </required_header>
  <id_info>
    <org_study_id>104-09062</org_study_id>
    <nct_id>NCT04459299</nct_id>
  </id_info>
  <brief_title>CorPath GRX STEMI Study</brief_title>
  <acronym>TREAT GRX</acronym>
  <official_title>An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corindus Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corindus Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI&#xD;
      (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, post-market, single-arm, multi-center, observational study to evaluate&#xD;
      the performance of the CorPath GRX System during robotic-PCI for acute ST elevation&#xD;
      myocardial infarction (STEMI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 28, 2020</start_date>
  <completion_date type="Anticipated">October 5, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</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>Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.</measure>
    <time_frame>Procedure</time_frame>
    <description>Time measured from arrival to Cath Lab to device activation by CorPath GRX System.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from MACE events</measure>
    <time_frame>72-hours</time_frame>
    <description>Completion of the STEMI procedure without in-hospital major adverse cardiovascular event MACE). MACE is defined as cardiac death, clinically driven target vessel revascularization (TVR) by repeat PCI, surgical bypass for any segment of the target vessel or stent thrombosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First Medical Contact (FMC) to device activation time</measure>
    <time_frame>Procedure</time_frame>
    <description>Time at which first patient evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access to device activation</measure>
    <time_frame>Procedure</time_frame>
    <description>Time measured from access sheath insertion to device activation by CorPath GRX System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access to wire time</measure>
    <time_frame>Procedure</time_frame>
    <description>Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall procedure time</measure>
    <time_frame>Procedure</time_frame>
    <description>Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>Procedure</time_frame>
    <description>Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient radiation exposure</measure>
    <time_frame>Procedure</time_frame>
    <description>DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast fluid volume</measure>
    <time_frame>Procedure</time_frame>
    <description>Total contrast volume (mL/cc) used during the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion to manual (Binary)</measure>
    <time_frame>Procedure</time_frame>
    <description>Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>Procedure</time_frame>
    <description>Completion of the PCI procedure entirely robotically or with partial manual assistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>72-hours</time_frame>
    <description>All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>STEMI - ST Elevation Myocardial Infarction</condition>
  <condition>CAD</condition>
  <arm_group>
    <arm_group_label>STEMI patients with clinical indication for primary PCI</arm_group_label>
    <description>Subjects with a clinical indication of STEMI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic-PCI (CorPath GRX System)</intervention_name>
    <description>Robotic-PCI for acute ST elevation myocardial infarction (STEMI).</description>
    <arm_group_label>STEMI patients with clinical indication for primary PCI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with a clinical indication of STEMI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 and ≤ 80 years&#xD;
&#xD;
          -  Patients with STEMI&lt;12 h of symptom onset&#xD;
&#xD;
          -  Patient deemed appropriate for robotic-assisted PCI&#xD;
&#xD;
          -  The subject has been informed of the nature of the study, agrees to its provisions,&#xD;
             and has provided written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cardiogenic shock&#xD;
&#xD;
          -  Cardiac arrest&#xD;
&#xD;
          -  Need for manual or mechanical thrombectomy&#xD;
&#xD;
          -  Failure/inability/unwillingness to provide informed consent&#xD;
&#xD;
          -  The Investigator determines that the subject or the coronary anatomy is not suitable&#xD;
             for robotic-assisted primary PCI treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salvatore F Mannino, DO, MA</last_name>
    <role>Study Chair</role>
    <affiliation>WellStar Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tina Ridgeway, BS, RN</last_name>
    <phone>757-810-5166</phone>
    <email>tina.ridgeway@corindus.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John Van Vleet, MS</last_name>
    <phone>(480) 819-7971</phone>
    <email>john.vanvleet@corindus.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wellstar Kennestone Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Lawson, MSN</last_name>
      <phone>470-793-4057</phone>
      <email>Susan.Lawson@wellstar.org</email>
    </contact>
    <investigator>
      <last_name>Salvatore F Mannino, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hirshfeld JW Jr, Balter S, Brinker JA, Kern MJ, Klein LW, Lindsay BD, Tommaso CL, Tracy CM, Wagner LK, Creager MA, Elnicki M, Lorell BH, Rodgers GP, Weitz HH; American College of Cardiology Foundation; American Heart Association/; HRS; SCAI; American College of Physicians Task Force on Clinical Competence and Training. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005 Feb 1;111(4):511-32. doi: 10.1161/01.CIR.0000157946.29224.5D. No abstract available.</citation>
    <PMID>15687141</PMID>
  </reference>
  <reference>
    <citation>Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801.</citation>
    <PMID>19214981</PMID>
  </reference>
  <reference>
    <citation>Miller DL, Schueler BA, Balter S; National Council on Radiation Protection and Measurements; International Commission on Radiological Protection. New recommendations for occupational radiation protection. J Am Coll Radiol. 2012 May;9(5):366-8. doi: 10.1016/j.jacr.2012.02.006. No abstract available.</citation>
    <PMID>22554637</PMID>
  </reference>
  <reference>
    <citation>Ciraj-Bjelac O, Rehani MM, Sim KH, Liew HB, Vano E, Kleiman NJ. Risk for radiation-induced cataract for staff in interventional cardiology: is there reason for concern? Catheter Cardiovasc Interv. 2010 Nov 15;76(6):826-34. doi: 10.1002/ccd.22670.</citation>
    <PMID>20549683</PMID>
  </reference>
  <reference>
    <citation>Vano E, Kleiman NJ, Duran A, Romano-Miller M, Rehani MM. Radiation-associated lens opacities in catheterization personnel: results of a survey and direct assessments. J Vasc Interv Radiol. 2013 Feb;24(2):197-204. doi: 10.1016/j.jvir.2012.10.016. Epub 2013 Jan 28.</citation>
    <PMID>23369556</PMID>
  </reference>
  <reference>
    <citation>Mahmud E, Naghi J, Ang L, Harrison J, Behnamfar O, Pourdjabbar A, Reeves R, Patel M. Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2017 Jul 10;10(13):1320-1327. doi: 10.1016/j.jcin.2017.03.050.</citation>
    <PMID>28683937</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be available 12 months after study completion.</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>June 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT04459299/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/NCT04459299
org study id: 104-09062
nct id: NCT04459299
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI
      (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).
This is a prospective, post-market, single-arm, multi-center, observational study to evaluate
      the performance of the CorPath GRX System during robotic-PCI for acute ST elevation
      myocardial infarction (STEMI).
observational model: Cohort
time perspective: Prospective
measure: Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.
time frame: Procedure
description: Time measured from arrival to Cath Lab to device activation by CorPath GRX System.
measure: Freedom from MACE events
time frame: 72-hours
description: Completion of the STEMI procedure without in-hospital major adverse cardiovascular event MACE). MACE is defined as cardiac death, clinically driven target vessel revascularization (TVR) by repeat PCI, surgical bypass for any segment of the target vessel or stent thrombosis.
measure: First Medical Contact (FMC) to device activation time
time frame: Procedure
description: Time at which first patient evaluation.
measure: Access to device activation
time frame: Procedure
description: Time measured from access sheath insertion to device activation by CorPath GRX System.
measure: Access to wire time
time frame: Procedure
description: Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.
measure: Overall procedure time
time frame: Procedure
description: Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.
measure: Fluoroscopy time
time frame: Procedure
description: Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.
measure: Patient radiation exposure
time frame: Procedure
description: DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.
measure: Contrast fluid volume
time frame: Procedure
description: Total contrast volume (mL/cc) used during the procedure.
measure: Conversion to manual (Binary)
time frame: Procedure
description: Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.
measure: Technical success
time frame: Procedure
description: Completion of the PCI procedure entirely robotically or with partial manual assistance.
measure: Serious adverse events
time frame: 72-hours
description: All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized.
arm group label: STEMI patients with clinical indication for primary PCI
description: Subjects with a clinical indication of STEMI.
intervention type: Procedure
intervention name: Robotic-PCI (CorPath GRX System)
description: Robotic-PCI for acute ST elevation myocardial infarction (STEMI).
arm group label: STEMI patients with clinical indication for primary PCI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Salvatore F Mannino, DO, MA
role: Study Chair
affiliation: WellStar Health System
last name: Tina Ridgeway, BS, RN
phone: 757-810-5166
email: tina.ridgeway@corindus.com
last name: John Van Vleet, MS
phone: (480) 819-7971
email: john.vanvleet@corindus.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Hirshfeld JW Jr, Balter S, Brinker JA, Kern MJ, Klein LW, Lindsay BD, Tommaso CL, Tracy CM, Wagner LK, Creager MA, Elnicki M, Lorell BH, Rodgers GP, Weitz HH; American College of Cardiology Foundation; American Heart Association/; HRS; SCAI; American College of Physicians Task Force on Clinical Competence and Training. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005 Feb 1;111(4):511-32. doi: 10.1161/01.CIR.0000157946.29224.5D. No abstract available.
PMID: 15687141
citation: Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801.
PMID: 19214981
citation: Miller DL, Schueler BA, Balter S; National Council on Radiation Protection and Measurements; International Commission on Radiological Protection. New recommendations for occupational radiation protection. J Am Coll Radiol. 2012 May;9(5):366-8. doi: 10.1016/j.jacr.2012.02.006. No abstract available.
PMID: 22554637
citation: Ciraj-Bjelac O, Rehani MM, Sim KH, Liew HB, Vano E, Kleiman NJ. Risk for radiation-induced cataract for staff in interventional cardiology: is there reason for concern? Catheter Cardiovasc Interv. 2010 Nov 15;76(6):826-34. doi: 10.1002/ccd.22670.
PMID: 20549683
citation: Vano E, Kleiman NJ, Duran A, Romano-Miller M, Rehani MM. Radiation-associated lens opacities in catheterization personnel: results of a survey and direct assessments. J Vasc Interv Radiol. 2013 Feb;24(2):197-204. doi: 10.1016/j.jvir.2012.10.016. Epub 2013 Jan 28.
PMID: 23369556
citation: Mahmud E, Naghi J, Ang L, Harrison J, Behnamfar O, Pourdjabbar A, Reeves R, Patel M. Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2017 Jul 10;10(13):1320-1327. doi: 10.1016/j.jcin.2017.03.050.
PMID: 28683937
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: Undecided
ipd description: Data will be available 12 months after study completion.
provided document: 