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/NCT05981859</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0838</org_study_id>
      <nct_id>NCT05981859</nct_id>
    </id_info>
    <brief_title>AVIAR(MX-02) Robotic-assisted Percutaneous Coronary Intervention</brief_title>
    <acronym>RoboticPCI</acronym>
    <official_title>Safety and Efficacy of PCI Cardiac Mapping System Workstation 'AVIAR (MX-02)' in Patients Undergoing Percutaneous Coronary Intervention (PCI): Prospective, Multi-center, Single-arm, Open, Post-approval Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Asan Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>LN Robotics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Asan Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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 efficacy of the steerable catheter&#xD;
        control system 'AVIAR(MX-02)', which remotely controls the guidewire and stent/balloon during&#xD;
        the percutaneous coronary intervention (PCI) for those who have suspected coronary artery&#xD;
        disease (CAD) and need PCI (for product approval from the MFDS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The potential subjects who meet the &quot;Coronary Angiography Selection/Exclusion Criteria&quot; are&#xD;
        eligible to be enrolled in the clinical trial. These individuals will undergo the standard&#xD;
        pre-procedural preparations and receive local anesthesia on the day of the procedure. The&#xD;
        angiography will be performed using the investigational medical device &quot;AVIAR (MX-02)&quot; via a&#xD;
        percutaneous coronary intervention procedure. After the procedure, the subjects will remain&#xD;
        in a supine position for approximately 4 hours in the recovery room or hospital room to&#xD;
        ensure absolute stability. During this time, the investigator will observe the puncture site&#xD;
        for hemostasis and monitor for any adverse events.&#xD;
  &#xD;
        Within 2 days after the procedure or prior to discharge, the subjects will undergo safety&#xD;
        assessments and evaluations for the occurrence of any adverse events or serious adverse&#xD;
        events. Additionally, at the 1-month follow-up, all required follow-up tests will be&#xD;
        completed, and if no adverse events have occurred or if any previously occurring adverse&#xD;
        events have been resolved, the clinical trial for that particular subject will be concluded.&#xD;
        However, if any adverse events remain unresolved and are deemed unrelated to the clinical&#xD;
        trial by the investigator, the trial may be terminated for that subject.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>1 Month</target_duration>
    <primary_outcome>
      <measure>Clinical Success Criteria</measure>
      <time_frame>48hours</time_frame>
      <description>If the residual stenosis rate of the lesion is less than 30% after completion of percutaneous coronary intervention using an investigational device If major adverse cardiovascular events (MACE)† have not occurred within 48 hours after the procedure or the time of discharge, whichever comes first</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Technical Success Criteria</measure>
      <time_frame>48hours</time_frame>
      <description>The stent (or balloon catheter) has successfully reached the target lesion without switching to manual manipulation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effective dose(mSv)</measure>
      <time_frame>48hours</time_frame>
      <description>The effective dose (mSv) is calculated as follows by multiplying the dose-length product (Dose-length product, DLP, mGy.cm) measured by the dosimeter on the chest of the subject and the operator and the weighting factor for each tissue</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Procedure time (min)</measure>
      <time_frame>48hours</time_frame>
      <description>- It is defined as the time from the manipulation of the guidewire using the investigational device to the removal of the guidewire.&#xD;
  Total procedure time(min)&#xD;
  - It is defined as the time from insertion of the arterial sheath to the point of removal of the sheath.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>TEAE</measure>
      <time_frame>1month</time_frame>
      <description>treatment emergent adverse event, TEAE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MACE</measure>
      <time_frame>1month</time_frame>
      <description>Major Adverse Cardiovascular Events) occurring in the study subjects during the clinical trial period.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Percutaneous Coronary Intervention</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Target number of participants for this clinical trial is a total of 20 patients during&#xD;
          study duration . If subjects who meet the &quot;Coronary Angiography Selection/Exclusion&#xD;
          Criteria&quot; are eligible to be enrolled in the clinical trial. These subjects will undergo&#xD;
          the standard pre-procedural preparations and receive local anesthesia on the day of the&#xD;
          procedure. The angiography will be performed using the investigational medical device&#xD;
          &quot;AVIAR (MX-02)&quot; via a percutaneous coronary intervention procedure.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  General Inclusion Criteria:&#xD;
  &#xD;
               1. Adult women and men who are aged ≥19 and &lt;75 years 2. Those who are suspected of&#xD;
               stable angina and need percutaneous coronary intervention 3. Those who voluntarily&#xD;
               decided to participate in this clinical trial and agreed in writing to the informed&#xD;
               consent form 4. Those who are willing to comply with the protocol&#xD;
  &#xD;
            -  Angiographic Inclusion Criteria:&#xD;
  &#xD;
                 1. If the lesion to be treated by coronary angiography (target lesion) is a native&#xD;
                    coronary artery lesion that has not been previously treated&#xD;
  &#xD;
                 2. If the diameter of the lesioned vessel to be treated by coronary angiography&#xD;
                    (target vessel) is between 2.5 mm and 4.5 mm (by visual estimate).&#xD;
  &#xD;
                 3. If diameter stenosis of the target vessel ≥50% (by visual estimate)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  General Exclusion Criteria:&#xD;
  &#xD;
                 1. Those with a left ventricular ejection fraction (LVEF) ≤ 30%&#xD;
  &#xD;
                 2. Those who have a history of hypersensitivity to contrast agents such as stainless&#xD;
                    steel, cobalt-chromium, etc.&#xD;
  &#xD;
                 3. Those who cannot stop taking antithrombotic drugs (anticoagulants, antiplatelet&#xD;
                    drugs)&#xD;
  &#xD;
                 4. Those diagnosed with thrombocytopenia, thrombocytosis, neutropenia, or leukopenia&#xD;
  &#xD;
                 5. Those who have a history of bleeding diathesis or coagulopathy or who refuse&#xD;
                    transfusion&#xD;
  &#xD;
                 6. Those with a history of stroke (CVA) or transient ischemic attack (TIA) within 4&#xD;
                    weeks from the screening date&#xD;
  &#xD;
                 7. .Those with a history of active peptic ulcer or upper gastrointestinal bleeding&#xD;
                    within 24 weeks from the screening date&#xD;
  &#xD;
                 8. Those with ST-elevation myocardial infarction (STEMI) (for example, those who&#xD;
                    started myocardial infarction symptoms within 72 hours from the screening date)&#xD;
  &#xD;
                 9. Those with a history of cardiogenic shock or cardiac arrest&#xD;
  &#xD;
                10. Those who underwent coronary artery bypass grafting (CABG)&#xD;
  &#xD;
                11. Those who underwent percutaneous coronary intervention (PCI) within 72 hours from&#xD;
                    the screening date&#xD;
  &#xD;
                12. Those who had a major adverse coronary event (MACE) or a serious adverse event&#xD;
                    (SAE) after receiving the percutaneous coronary intervention (PCI) within 4 weeks&#xD;
                    from the screening date&#xD;
  &#xD;
                13. Those who are scheduled to undergo percutaneous coronary intervention (PCI) or&#xD;
                    coronary artery bypass grafting (CABG) within 4 weeks from the end of this&#xD;
                    clinical trial&#xD;
  &#xD;
                14. Those diagnosed with renal failure or those who are not suitable for angiography&#xD;
                    due to severe renal dysfunction (creatine &gt; 2.0 mg/dL or eGFR (estimated&#xD;
                    glomerular filtration rate) &lt; 30 ml/min) within one week prior to the date of&#xD;
                    coronary angiography&#xD;
  &#xD;
                15. Pregnant and breastfeeding women&#xD;
  &#xD;
                16. Women of childbearing potential who plan to become pregnant during this clinical&#xD;
                    trial&#xD;
  &#xD;
                17. A woman* or spouse who is likely to be pregnant does not agree to use&#xD;
                    contraception in a medically acceptable method of contraception** during the&#xD;
                    clinical trial&#xD;
  &#xD;
                    * Pregnant women who have experienced first trimester (who have undergone&#xD;
                    surgical infertility (either uterine extraction or bilateral ovarian resection)&#xD;
                    or who have been defined as menopause for more than 12 months without any other&#xD;
                    reason are not women of childbearing age)&#xD;
  &#xD;
                      -  Hormonal contraception, vasectomy, intrauterine device (IUD) or IUS&#xD;
                         [intrauterine system], tubular ligation, double blocking (complex use of&#xD;
                         blocking methods such as condoms for men, condoms for women, cervical caps,&#xD;
                         contraceptive diaphragm, contraceptive sponge), and sanitizers a one-off&#xD;
                         method&#xD;
  &#xD;
                18. Those who are currently participating in other clinical trials or have experience&#xD;
                    participating in other clinical trials within 12 weeks from the screening date&#xD;
  &#xD;
                19. Other cases where the investigator determines that participation in a clinical&#xD;
                    trial is inappropriate ethically or because it may affect the study outcome.&#xD;
  &#xD;
                    ☞The specific reason is recorded in the CRF&#xD;
  &#xD;
            -  Angiographic Exclusion Criteria:&#xD;
  &#xD;
                 1. Those who require manual or mechanical thrombectomy, rotational atherectomy,&#xD;
                    directional coronary atherectomy (DCA), etc. in addition to stent placement and&#xD;
                    balloon dilatation&#xD;
  &#xD;
                 2. If there are two or more target vessels&#xD;
  &#xD;
                 3. If there are two or more target lesions in one blood vessel&#xD;
  &#xD;
                 4. Any previous stent placement within 5 mm (proximal or distal) of the target&#xD;
                    lesion&#xD;
  &#xD;
                 5. When the investigator determines that PCI is not suitable because the target&#xD;
                    lesion hasany of the following characteristics:&#xD;
  &#xD;
                      -  Is severely tortuous ≥45°&#xD;
  &#xD;
                           -  An ostial lesion in location ③The target vessel has evidence of&#xD;
                              intraluminal thrombus or severe tortuosity (&gt; 90°) proximal to the&#xD;
                              target lesion ④Moderate or severe calcification at the target lesion or&#xD;
                              near the target lesion ⑤Target lesion that is located in a native&#xD;
                              vessel distal to an anastomosis with a saphenous vein graft or a&#xD;
                              left/right internal mammary artery (LIMA/RIMA) bypass and is approached&#xD;
                              through the by-pass graft ⑥If PCI cannot be performed for other&#xD;
                              reasons☞The specific reason is recorded in the CRF&#xD;
  &#xD;
                 6. Unprotected left main coronary artery disease (an obstruction greater than 50%&#xD;
                    diameter stenosis in the left main coronary artery)&#xD;
  &#xD;
                 7. If the investigator determines that the subject is not suitable for&#xD;
                    robotic-assisted PCI due to clinical and anatomical reasons.☞The specific reason&#xD;
                    is recorded in the CRF.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jung hwa Lee, RN</last_name>
      <phone>82-2045-3398</phone>
      <email>nurse9726@amc.seoul.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Seung-Whan Lee, MD</last_name>
      <phone>82 2-3010-3170</phone>
      <email>seungwlee@amc.seoul.kr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Asan Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Seung-Whan Lee, MD</last_name>
      </contact>
      <investigator>
        <last_name>Seung-Whan Lee, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tae Oh Kim, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea Eunpyeong St. Mary's Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Junghoon Lee, MD</last_name>
        <email>me@leejunghoon.com</email>
      </contact>
      <contact_backup>
        <last_name>Osung Kwon, MD</last_name>
      </contact_backup>
      <investigator>
        <last_name>Junghoon Lee, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Osung Kwon</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Asan Medical Center</investigator_affiliation>
      <investigator_full_name>Seung-Whan Lee, M.D., Ph.D.</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <keyword>Robotic PCI</keyword>
    <!-- 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/NCT05981859
  org study id: 2023-0838
  nct id: NCT05981859
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the safety and efficacy of the steerable catheter
        control system 'AVIAR(MX-02)', which remotely controls the guidewire and stent/balloon during
        the percutaneous coronary intervention (PCI) for those who have suspected coronary artery
        disease (CAD) and need PCI (for product approval from the MFDS).
  The potential subjects who meet the "Coronary Angiography Selection/Exclusion Criteria" are
        eligible to be enrolled in the clinical trial. These individuals will undergo the standard
        pre-procedural preparations and receive local anesthesia on the day of the procedure. The
        angiography will be performed using the investigational medical device "AVIAR (MX-02)" via a
        percutaneous coronary intervention procedure. After the procedure, the subjects will remain
        in a supine position for approximately 4 hours in the recovery room or hospital room to
        ensure absolute stability. During this time, the investigator will observe the puncture site
        for hemostasis and monitor for any adverse events.
  
        Within 2 days after the procedure or prior to discharge, the subjects will undergo safety
        assessments and evaluations for the occurrence of any adverse events or serious adverse
        events. Additionally, at the 1-month follow-up, all required follow-up tests will be
        completed, and if no adverse events have occurred or if any previously occurring adverse
        events have been resolved, the clinical trial for that particular subject will be concluded.
        However, if any adverse events remain unresolved and are deemed unrelated to the clinical
        trial by the investigator, the trial may be terminated for that subject.
  observational model: Cohort
  time perspective: Prospective
  measure: Clinical Success Criteria
  time frame: 48hours
  description: If the residual stenosis rate of the lesion is less than 30% after completion of percutaneous coronary intervention using an investigational device If major adverse cardiovascular events (MACE)† have not occurred within 48 hours after the procedure or the time of discharge, whichever comes first
  measure: Technical Success Criteria
  time frame: 48hours
  description: The stent (or balloon catheter) has successfully reached the target lesion without switching to manual manipulation
  measure: Effective dose(mSv)
  time frame: 48hours
  description: The effective dose (mSv) is calculated as follows by multiplying the dose-length product (Dose-length product, DLP, mGy.cm) measured by the dosimeter on the chest of the subject and the operator and the weighting factor for each tissue
  measure: Procedure time (min)
  time frame: 48hours
  description: - It is defined as the time from the manipulation of the guidewire using the investigational device to the removal of the guidewire.
  Total procedure time(min)
  - It is defined as the time from insertion of the arterial sheath to the point of removal of the sheath.
  measure: TEAE
  time frame: 1month
  description: treatment emergent adverse event, TEAE
  measure: MACE
  time frame: 1month
  description: Major Adverse Cardiovascular Events) occurring in the study subjects during the clinical trial period.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jung hwa Lee, RN
  phone: 82-2045-3398
  email: nurse9726@amc.seoul.kr
  last name: Seung-Whan Lee, MD
  phone: 82 2-3010-3170
  email: seungwlee@amc.seoul.kr
  facility: 
  contact: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Asan Medical Center
  investigator full name: Seung-Whan Lee, M.D., Ph.D.
  investigator title: Principle Investigator