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/NCT06030271</url>
    </required_header>
    <id_info>
      <org_study_id>CIP-003C</org_study_id>
      <nct_id>NCT06030271</nct_id>
    </id_info>
    <brief_title>A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter</brief_title>
    <official_title>A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Insight Lifetech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Insight Lifetech 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 trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal&#xD;
        clinical investigation to demonstrate the safety and performance of the TrueCross Single-use&#xD;
        Microcatheter.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this clinical investigation is to evaluate the performance and safety of the&#xD;
        TrueCross Single-use Microcatheter in patients requiring a PCI procedure as well as the&#xD;
        related clinical benefits.&#xD;
  &#xD;
        The study will include 59 subjects suffering from coronary artery disease requiring a&#xD;
        percutaneous coronary intervention. Enrollment duration will be 4 months or so without&#xD;
        follow-up. It is a single-arm trial.In the uneventual case of a potential dropout (serious&#xD;
        protocol deviation or procedure interruption unrelated to the catheter), subjects will be&#xD;
        replaced to reach 59 evaluable subjects for the Per Protocol population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 13, 2022</start_date>
    <completion_date type="Actual">March 30, 2023</completion_date>
    <primary_completion_date type="Actual">March 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical Performance-technical success</measure>
      <time_frame>during the procedure</time_frame>
      <description>Angiographic confirmation of the TrueCross Single-use Microcatheter's ability to support the guidewire in crossing the CTO in the target vessel true lumen.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety-observation of AE</measure>
      <time_frame>ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure</time_frame>
      <description>Occurrence of any device related adverse event during use of the microcatheter throughout the procedure.&#xD;
  Occurrence of any non-device/procedure related events from screening start to the end of the procedure. This will include any events related or cause by other devices used independently from the TrueCross Single-use Microcatheter during the same PCI procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Performance/Effectiveness</measure>
      <time_frame>during the procedure</time_frame>
      <description>Angiographic confirmation of successful placement and successful injection of contrast medium into the vessel lumen,&#xD;
  Ability of exchange of the guidewire,&#xD;
  Safe withdrawal of the TrueCross Single-use Microcatheter.&#xD;
  Procedural efficiency measures (procedure time and injected contrast volume).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Coronary Artery Disease Obliterative</condition>
    <condition>Chronic Total Occlusion (CTO)</condition>
    <arm_group>
      <arm_group_label>TrueCross microcatheter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Microcatheter</intervention_name>
      <description>Support and facilitate the placement of the guidewire in the coronary artery with a CTO.</description>
      <arm_group_label>TrueCross microcatheter</arm_group_label>
      <other_name>TrueCross</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          i. Subjects who are &gt;25 years of age. ii. Subjects who are able/willing to provide a&#xD;
          written informed consent prior to participating in the clinical investigation.&#xD;
  &#xD;
          iii. The subject is male or, if female, is either not of childbearing potential or must use&#xD;
          effective contraception during participation in this Clinical Investigation.&#xD;
  &#xD;
          iv. Subject suffering from coronary artery disease requiring percutaneous coronary&#xD;
          angiography and/or intervention.&#xD;
  &#xD;
          v. Lesions classified as CTOs, meaning, TIMI 0 flow within the occluded segment and&#xD;
          angiographic or clinical evidence or high likelihood of an occlusion duration &gt; 3 months&#xD;
          vi. Reference vessel diameter ≥2 mm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          i. Coronary angiography and/or intervention contraindications. ii. Subjects with severe&#xD;
          arrhythmia. iii. Subjects with severe systemic infection. iv. Subjects with severe&#xD;
          coagulation disorder. v. Subjects with severe heart failure, unstable decompensated heart&#xD;
          failure, congestive heart failure, or dyspnea who are unable to lie supine on the&#xD;
          examination table for angiography.&#xD;
  &#xD;
          vi. Subjects with prior coronary artery spams or prior heart valve replacement. vii.&#xD;
          Currently participating in an investigational drug or another device clinical investigation&#xD;
          that has not completed the primary endpoint or that clinically interferes with the current&#xD;
          clinical investigation endpoints.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>26 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Israeli-Georgian Medical Research Clinic Ltd - Healthycore Clinic</name>
        <address>
          <city>Tbilisi</city>
          <country>Georgia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tbilisi Heart and Vascular Clinic</name>
        <address>
          <city>Tbilisi</city>
          <country>Georgia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tbilisi Institute of Medicine</name>
        <address>
          <city>Tbilisi</city>
          <country>Georgia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic</name>
        <address>
          <city>Tbilisi</city>
          <country>Georgia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Onassis Heart Surgery Centre</name>
        <address>
          <city>Athens</city>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Red Cross General Hospital</name>
        <address>
          <city>Athens</city>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>National Heart Centre Singapore</name>
        <address>
          <city>Singapore</city>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Georgia</country>
      <country>Greece</country>
      <country>Singapore</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>microcatheter, CTO, coronary artery disease, PCI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT06030271
  org study id: CIP-003C
  nct id: NCT06030271
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal
        clinical investigation to demonstrate the safety and performance of the TrueCross Single-use
        Microcatheter.
  The objective of this clinical investigation is to evaluate the performance and safety of the
        TrueCross Single-use Microcatheter in patients requiring a PCI procedure as well as the
        related clinical benefits.
  
        The study will include 59 subjects suffering from coronary artery disease requiring a
        percutaneous coronary intervention. Enrollment duration will be 4 months or so without
        follow-up. It is a single-arm trial.In the uneventual case of a potential dropout (serious
        protocol deviation or procedure interruption unrelated to the catheter), subjects will be
        replaced to reach 59 evaluable subjects for the Per Protocol population.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Clinical Performance-technical success
  time frame: during the procedure
  description: Angiographic confirmation of the TrueCross Single-use Microcatheter's ability to support the guidewire in crossing the CTO in the target vessel true lumen.
  measure: Safety-observation of AE
  time frame: ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure
  description: Occurrence of any device related adverse event during use of the microcatheter throughout the procedure.
  Occurrence of any non-device/procedure related events from screening start to the end of the procedure. This will include any events related or cause by other devices used independently from the TrueCross Single-use Microcatheter during the same PCI procedure.
  measure: Clinical Performance/Effectiveness
  time frame: during the procedure
  description: Angiographic confirmation of successful placement and successful injection of contrast medium into the vessel lumen,
  Ability of exchange of the guidewire,
  Safe withdrawal of the TrueCross Single-use Microcatheter.
  Procedural efficiency measures (procedure time and injected contrast volume).
  arm group label: TrueCross microcatheter
  arm group type: Experimental
  description: The TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects.
  intervention type: Device
  intervention name: Microcatheter
  description: Support and facilitate the placement of the guidewire in the coronary artery with a CTO.
  arm group label: TrueCross microcatheter
  other name: TrueCross
  criteria: 
  gender: All
  minimum age: 26 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: Georgia
  country: Greece
  country: Singapore
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease