xml: <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/NCT06032572</url>
    </required_header>
    <id_info>
      <org_study_id>VRS100 System</org_study_id>
      <nct_id>NCT06032572</nct_id>
    </id_info>
    <brief_title>Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)</brief_title>
    <official_title>Evaluation of the Safety and Effectiveness of the VRS100 Robotic Console System in Percutaneous Coronary Interventions: A Multicenter, Randomised, Non-inferiority Trial (ESSENCE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shenzhen Raysight Intelligent Medical Technology Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>West China Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shenzhen People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shenzhen Raysight Intelligent Medical Technology Co., Ltd.</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 objective of this study is to evaluate the safety and effectiveness of the clinical and&#xD;
        technical performance of the VRS100 system with disposable surgical kit in the delivery and&#xD;
        manipulation of coronary guidewires and stent/balloon systems for use in percutaneous&#xD;
        coronary interventions (PCI).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical Success</measure>
      <time_frame>48-hrs or hospital discharge, whichever occurs first</time_frame>
      <description>Defined as angiographic success (residual stenosis after stenting of &lt;30% with final TIMI [Thrombolysis In Myocardial Infarction] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (cardiovascular death, MI, clinically driven target vessel revascularization).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Technical Success</measure>
      <time_frame>1 day</time_frame>
      <description>Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PCI Procedure Time</measure>
      <time_frame>During 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>Overall Procedure Time</measure>
      <time_frame>During 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>Fluoroscopy and/or X-Ray Time</measure>
      <time_frame>During procedure</time_frame>
      <description>As recorded by an X-Ray System utilized during the procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Radiation Exposure - Cumulative Dose</measure>
      <time_frame>During procedure</time_frame>
      <description>Cumulative dose (mGy) as recored during the procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Contrast Fluid Volume</measure>
      <time_frame>During procedure</time_frame>
      <description>The amount of contrast fluid used (mL) during the procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance of the Experimental Device</measure>
      <time_frame>During procedure</time_frame>
      <description>The frequency of failures and performance evaluation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">204</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Cardiovascular Diseases</condition>
    <condition>Coronary Disease</condition>
    <condition>Myocardial Ischemia</condition>
    <condition>Arteriosclerosis</condition>
    <condition>Vascular Disease Occlusive</condition>
    <arm_group>
      <arm_group_label>VRS100 robotic-assisted PCI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>VRS100 robotic-assisted PCI</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Manual PCI</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Manual PCI</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>VRS100 robotic-assisted PCI</intervention_name>
      <description>The VRS100 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>
      <arm_group_label>VRS100 robotic-assisted PCI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Manual PCI</intervention_name>
      <description>Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.</description>
      <arm_group_label>Manual PCI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  General Inclusion Criteria:&#xD;
  &#xD;
                 1. Age ≥18 years.&#xD;
  &#xD;
                 2. Patients with coronary artery disease undergoing Percutaneous Coronary&#xD;
                    Intervention (PCI).&#xD;
  &#xD;
                 3. The subject has been informed of the nature of the study, agrees to its&#xD;
                    provisions and has provided written informed consent.&#xD;
  &#xD;
            -  Angiographic Inclusion Criteria:&#xD;
  &#xD;
                 1. In situ primary coronary vascular disease.&#xD;
  &#xD;
                 2. Reference vessel diameter is 2.5-4.0mm by visual estimate.&#xD;
  &#xD;
                 3. Target lesion length is ≤30.0mm.&#xD;
  &#xD;
                 4. Target lesion is a single de novo native coronary artery lesion. This lesion may&#xD;
                    consist of multiple lesions (with ≤10mm between diseased segments) and must be&#xD;
                    completely covered by a single stent with ≥5.0mm of normal segments on proximal&#xD;
                    and distal edges of the lesion.&#xD;
  &#xD;
                 5. Target lesion diameter showing stenosis ≥70% by visual estimate, or ≥50% with&#xD;
                    myocardial ischemia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients meeting any of the following criteria will be excluded:&#xD;
  &#xD;
            -  General Exclusion Criteria:&#xD;
  &#xD;
                 1. Subjects with indications for urgent PCI surgery.&#xD;
  &#xD;
                 2. Evidence of an acute myocardial infarction within one week prior to the intended&#xD;
                    VRS100 procedure.&#xD;
  &#xD;
                 3. Subject has undergone PCI within 72 hours prior to the VRS100 procedure.&#xD;
  &#xD;
                 4. Subject has undergone PCI within 30 days prior to the VRS100 procedure and&#xD;
                    experienced a MACE or a serious adverse event (SAE).&#xD;
  &#xD;
                 5. Severe heart failure (NYHA IV).&#xD;
  &#xD;
                 6. Subject has suffered a stroke, or has an active peptic ulcer or upper&#xD;
                    gastrointestinal bleeding within 6 months prior to planned VRS100 procedure.&#xD;
  &#xD;
                 7. Subject has known hypersensitivity or contraindication to aspirin, heparin,&#xD;
                    ticagrelor, clopidogrel, bivalirudin, PTX(paclitaxel), stainless steel, etc.&#xD;
  &#xD;
                 8. Subject has acute or chronic kidney disease (serum creatinine level of &gt;2.5 mg/dL&#xD;
                    or &gt;221 umol/L) or need dialysis.&#xD;
  &#xD;
                 9. Pregnant or breastfeeding, or planning to be pregnant.&#xD;
  &#xD;
                10. Repeated enrollment.&#xD;
  &#xD;
                11. Any other factors that the researchers consider not suitable for inclusion or&#xD;
                    completion of this study.&#xD;
  &#xD;
            -  Angiographic Exclusion Criteria:&#xD;
  &#xD;
                 1. Any previous stent placement within 5.0 mm (proximal or distal) of the target&#xD;
                    lesion.&#xD;
  &#xD;
                 2. The study lesion requires planned treatment with directional coronary atherectomy&#xD;
                    (DCA), laser, rotational atherectomy or any device except for balloon dilatation&#xD;
                    prior to stent placement.&#xD;
  &#xD;
                 3. Cardiac allograft vasculopathy (CAV).&#xD;
  &#xD;
                 4. The study vessel has evidence of intraluminal thrombus.&#xD;
  &#xD;
                 5. Chronic total occlusion (CTO).&#xD;
  &#xD;
                 6. The study lesion located in a native vessel distal to an ostial, bifurcation or&#xD;
                    anastomosis.&#xD;
  &#xD;
                 7. Unprotected left main coronary artery disease defined as an obstruction greater&#xD;
                    than 50% diameter stenosis in the left main coronary artery.&#xD;
  &#xD;
                 8. The study lesion or vessel proximal to the target lesion has severe tortuosity or&#xD;
                    calcification.&#xD;
  &#xD;
                 9. Target lesion that cannot be fully covered by a single stent.&#xD;
  &#xD;
                10. more than 2 lesions requires treatment in one vessel.&#xD;
  &#xD;
                11. Subject requires treatment of more than one vessel.&#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>Junbo Ge</last_name>
      <role>Study Director</role>
      <affiliation>Shanghai Zhongshan Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yong He</last_name>
      <role>Principal Investigator</role>
      <affiliation>West China Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Da Yin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shenzhen People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lihui Li</last_name>
      <phone>13636480344</phone>
      <email>lihui.li@raysightmed.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shenzhen People's Hospital</name>
        <address>
          <city>Shenzhen</city>
          <state>Guangdong</state>
          <zip>518020</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Zhongshan Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>West China Hospital of Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuang</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Cardiovascular Diseases</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
      <mesh_term>Vascular Diseases</mesh_term>
      <mesh_term>Arteriosclerosis</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032572
  org study id: VRS100 System
  nct id: NCT06032572
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the safety and effectiveness of the clinical and
        technical performance of the VRS100 system with disposable surgical kit in the delivery and
        manipulation of coronary guidewires and stent/balloon systems for use in percutaneous
        coronary interventions (PCI).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Clinical Success
  time frame: 48-hrs or hospital discharge, whichever occurs first
  description: Defined as angiographic success (residual stenosis after stenting of <30% with final TIMI [Thrombolysis In Myocardial Infarction] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (cardiovascular death, MI, clinically driven target vessel revascularization).
  measure: Technical Success
  time frame: 1 day
  description: Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.
  measure: PCI Procedure Time
  time frame: During procedure
  description: Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
  measure: Overall Procedure Time
  time frame: During procedure
  description: Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
  measure: Fluoroscopy and/or X-Ray Time
  time frame: During procedure
  description: As recorded by an X-Ray System utilized during the procedure.
  measure: Patient Radiation Exposure - Cumulative Dose
  time frame: During procedure
  description: Cumulative dose (mGy) as recored during the procedure.
  measure: Contrast Fluid Volume
  time frame: During procedure
  description: The amount of contrast fluid used (mL) during the procedure.
  measure: Performance of the Experimental Device
  time frame: During procedure
  description: The frequency of failures and performance evaluation
  arm group label: VRS100 robotic-assisted PCI
  arm group type: Experimental
  description: VRS100 robotic-assisted PCI
  arm group label: Manual PCI
  arm group type: Active Comparator
  description: Manual PCI
  intervention type: Procedure
  intervention name: VRS100 robotic-assisted PCI
  description: The VRS100 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.
  arm group label: VRS100 robotic-assisted PCI
  intervention type: Procedure
  intervention name: Manual PCI
  description: Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.
  arm group label: Manual PCI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Junbo Ge
  role: Study Director
  affiliation: Shanghai Zhongshan Hospital
  last name: Yong He
  role: Principal Investigator
  affiliation: West China Hospital
  last name: Da Yin
  role: Principal Investigator
  affiliation: Shenzhen People's Hospital
  last name: Lihui Li
  phone: 13636480344
  email: lihui.li@raysightmed.com
  facility: 
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  mesh term: Vascular Diseases
  mesh term: Arteriosclerosis
  mesh term: Ischemia
  sharing ipd: No