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/NCT05965037</url>
    </required_header>
    <id_info>
      <org_study_id>C32103</org_study_id>
      <nct_id>NCT05965037</nct_id>
    </id_info>
    <brief_title>The FLUYDO NC Post Market Clinical Follow-up Study</brief_title>
    <official_title>Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alvimedica</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CID S.p.A.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Alvimedica</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 aim of the present observational study is to collect clinical data on the medical device&#xD;
        non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon&#xD;
        dilatation catheter in the daily use in a not selected population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Device success</measure>
      <time_frame>immediately after interventional procedure</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Successful inflation, achievement of appropriate diameter, and deflation of the balloon</measure>
      <time_frame>immediately after interventional procedure</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Decrease in the percent stenosis after balloon procedure</measure>
      <time_frame>immediately after interventional procedure</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade</measure>
      <time_frame>immediately after interventional procedure</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)</measure>
      <time_frame>immediately after interventional procedure</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Procedural success: Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR))</measure>
      <time_frame>Discharge or 48 hours after index procedure, whichever happens first</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.</measure>
      <time_frame>discharge or 48 hours after index procedure, whichever happens first</time_frame>
    </secondary_outcome>
    <enrollment type="Actual">100</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Coronary Disease</condition>
    <condition>Vascular Diseases</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter</intervention_name>
      <description>The FLUYDO NC is a rapid exchange percutaneous transluminal non-compliant coronary angioplasty balloon catheter. It is a single use only medical device, non-implantable, non-pyrogenic and sterilized with ethylene oxide and CO2 mixture. The distal portion has a hydrophilic coating and consists of two lumens: one for balloon inflation and deflation, the other for guidewire advancement and retraction. The product is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive patients meeting the patient selection criteria, over 18 years old, eligible&#xD;
          for a catheter with FLUYDO NC catheter.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Turkish citizen,&#xD;
  &#xD;
            -  ≥18 years of age,&#xD;
  &#xD;
            -  Has indication for percutaneous transluminal coronary angioplasty (PTCA),&#xD;
  &#xD;
            -  Has indication to treat obstructive lesions of a native coronary artery or&#xD;
               aortocoronary bypass or needs post dilatation of coronary stent&#xD;
  &#xD;
            -  Fluydo NC using in the primary lesion treated during the procedure by the decision&#xD;
               physician,&#xD;
  &#xD;
            -  Has signed and dated the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a previous diagnosis of coronary artery spasm in the absence of a significant&#xD;
               stenosis.&#xD;
  &#xD;
            -  Needs the device use in an unprotected left main coronary artery&#xD;
  &#xD;
            -  Device use has not consistent with Instructions for Use.&#xD;
  &#xD;
            -  Participating in another medical device or pharmaceutical clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Alvimedica</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 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>Coronary Artery Disease</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
      <mesh_term>Vascular Diseases</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/NCT05965037
  org study id: C32103
  nct id: NCT05965037
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the present observational study is to collect clinical data on the medical device
        non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon
        dilatation catheter in the daily use in a not selected population.
  observational model: Other
  time perspective: Prospective
  measure: Device success
  time frame: immediately after interventional procedure
  measure: Successful inflation, achievement of appropriate diameter, and deflation of the balloon
  time frame: immediately after interventional procedure
  measure: Decrease in the percent stenosis after balloon procedure
  time frame: immediately after interventional procedure
  measure: No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade
  time frame: immediately after interventional procedure
  measure: No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
  time frame: immediately after interventional procedure
  measure: Procedural success: Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR))
  time frame: Discharge or 48 hours after index procedure, whichever happens first
  measure: Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.
  time frame: discharge or 48 hours after index procedure, whichever happens first
  intervention type: Device
  intervention name: FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter
  description: The FLUYDO NC is a rapid exchange percutaneous transluminal non-compliant coronary angioplasty balloon catheter. It is a single use only medical device, non-implantable, non-pyrogenic and sterilized with ethylene oxide and CO2 mixture. The distal portion has a hydrophilic coating and consists of two lumens: one for balloon inflation and deflation, the other for guidewire advancement and retraction. The product is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Coronary Disease
  mesh term: Vascular Diseases