<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/NCT03278301</url>
  </required_header>
  <id_info>
    <org_study_id>2017-001</org_study_id>
    <nct_id>NCT03278301</nct_id>
  </id_info>
  <brief_title>PRECISION GRX Registry</brief_title>
  <official_title>A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To collect data on the routine patterns of use, safety and effectiveness, including the&#xD;
      clinical and technical performance of the CorPath GRX System, in the delivery and&#xD;
      manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide&#xD;
      catheters during PCI procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to&#xD;
      examine its performance during PCI procedures and patient outcomes through 72 hours&#xD;
      post-procedure or hospital discharge, whichever occurs first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2017</start_date>
  <completion_date type="Actual">February 6, 2020</completion_date>
  <primary_completion_date type="Actual">February 6, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Days</target_duration>
  <primary_outcome>
    <measure>Clinical Success</measure>
    <time_frame>Discharge or 72 hours post intervention, whichever comes first.</time_frame>
    <description>Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Procedure</time_frame>
    <description>Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Procedure Time</measure>
    <time_frame>Procedure</time_frame>
    <description>Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCI Procedure Time</measure>
    <time_frame>Procedure</time_frame>
    <description>Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Time</measure>
    <time_frame>Procedure</time_frame>
    <description>Total Fluoroscopy Time during procedure will be captured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Radiation Exposure</measure>
    <time_frame>Procedure</time_frame>
    <description>DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.</description>
  </secondary_outcome>
  <enrollment type="Actual">952</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic-assisted PCI</intervention_name>
    <description>The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with coronary artery disease and with a clinical indication for PCI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Candidates will be included in the study only if all of the following conditions are met:&#xD;
&#xD;
          1. Age ≥18 years;&#xD;
&#xD;
          2. Patients with coronary artery disease with clinical indication for PCI;&#xD;
&#xD;
          3. Patient deemed appropriate for robotic-assisted PCI; and&#xD;
&#xD;
          4. The subject has been informed of the nature of the study, agrees to its provisions and&#xD;
             has provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Candidates will be excluded from the study if any of the following conditions are&#xD;
             present:&#xD;
&#xD;
               1. Failure/inability/unwillingness to provide informed consent; or&#xD;
&#xD;
               2. The investigator determines that the patient or the coronary anatomy is not&#xD;
                  suitable for robotic-assisted PCI.&#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>Ehtisham Mahmud, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC San Diego Health Sulpizio Cardiovascular Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health Hospitals Fred and Lena Meijer Heart Center</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital - Troy</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WakeMed Raleigh Campus</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Einstein Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellspan York Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson-Madison County General Hospital</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Jack and Jane Hamilton Heart and Vascular Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White All Saints Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System University Hospital</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Einstein Israelite Hospital</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>05652-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Heart Institute</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380059</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>India</country>
    <country>Singapore</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>Coronary Artery 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/NCT03278301
org study id: 2017-001
nct id: NCT03278301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To collect data on the routine patterns of use, safety and effectiveness, including the
      clinical and technical performance of the CorPath GRX System, in the delivery and
      manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide
      catheters during PCI procedures.
This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to
      examine its performance during PCI procedures and patient outcomes through 72 hours
      post-procedure or hospital discharge, whichever occurs first.
observational model: Cohort
time perspective: Prospective
measure: Clinical Success
time frame: Discharge or 72 hours post intervention, whichever comes first.
description: Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).
measure: Technical Success
time frame: Procedure
description: Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
measure: Overall Procedure Time
time frame: Procedure
description: Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
measure: PCI Procedure Time
time frame: Procedure
description: Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
measure: Fluoroscopy Time
time frame: Procedure
description: Total Fluoroscopy Time during procedure will be captured.
measure: Patient Radiation Exposure
time frame: Procedure
description: DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
intervention type: Device
intervention name: Robotic-assisted PCI
description: The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ehtisham Mahmud, MD
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
facility: 
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country: Brazil
country: India
country: Singapore
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No