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/NCT05998252</url>
    </required_header>
    <id_info>
      <org_study_id>S01</org_study_id>
      <nct_id>NCT05998252</nct_id>
    </id_info>
    <brief_title>Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis</brief_title>
    <official_title>A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BrosMed Medical Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BrosMed Medical Co., Ltd</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, multi-center, single-group study aims to evaluate the safety and&#xD;
        efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery&#xD;
        stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI,&#xD;
        and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up&#xD;
        of the subjects will be recorded, and the safety and efficacy of the investigational device&#xD;
        will be evaluated.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 27, 2022</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Procedural Success Rate</measure>
      <time_frame>7 days</time_frame>
      <description>Defined as meeting all the following criteria:&#xD;
  After PCI, the target lesion achieves a final diameter stenosis of ≤30%, and the TIMI grade of 3;&#xD;
  No all-cause mortality, Q-wave myocardial infarction, stroke, cardiac tamponade, or target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) during postoperative follow-up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Device Success Rate</measure>
      <time_frame>0 day</time_frame>
      <description>Defined as meeting all the following criteria:&#xD;
  Successful delivery to the target location, completely pre-dilatation and successful withdrawal by using Alveo HP Balloon Dilatation Catheter;&#xD;
  No evidence of arterial perforation, flow-restricted dissection, decreased TIMI grade while using the device, or no clinically significant arrhythmias after pre-dilatation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device Performance Evaluation</measure>
      <time_frame>0 day</time_frame>
      <description>The investigators will evaluate the device performance according to the use and operation of the device during the procedure. Evaluate performance of balloon catheter delivery, inflation, deflation, and withdrawal, etc. There are 5 levels ranging from poor to excellent, higher scores indicate better performance.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Incidence of major adverse cardiac events (MACE) during the study.</measure>
      <time_frame>0 - 7 days</time_frame>
      <description>Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse events and serious adverse events rate</measure>
      <time_frame>0 - 7 days</time_frame>
      <description>Adverse events and serious adverse events related to the study device during the study.</description>
    </other_outcome>
    <other_outcome>
      <measure>Other Adverse events and serious adverse events rate</measure>
      <time_frame>0 - 7 days</time_frame>
      <description>Occurrence of other adverse events and serious adverse events</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Alveo balloon dilatation catheter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with Alveo balloon dilatation catheter.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Alveo HP Balloon Dilatation Catheter</intervention_name>
      <description>Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.</description>
      <arm_group_label>Alveo balloon dilatation catheter</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years old, gender is not limited;&#xD;
  &#xD;
            2. Patients with symptomatic ischemic heart disease who are suitable for percutaneous&#xD;
               coronary intervention (PCI);&#xD;
  &#xD;
            3. Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total&#xD;
               occlusion (CTO) who needed balloon dilatation catheter pre-dilatation;&#xD;
  &#xD;
            4. Patients or their guardians who can understand the purpose of the trial, voluntarily&#xD;
               participate and sign the written informed consent, and can accept follow-up;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with clinical symptoms consistent with ST-segment elevation myocardial&#xD;
               infarction or/and ECG changes within 12 hours prior to the procedure;&#xD;
  &#xD;
            2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast&#xD;
               media;&#xD;
  &#xD;
            3. Patients with in-stent restenosis;&#xD;
  &#xD;
            4. Patients with unprotected left main coronary artery disease;&#xD;
  &#xD;
            5. Patients who plan to treat 3 or more lesions at the same time;&#xD;
  &#xD;
            6. Patients with severe calcified lesions;&#xD;
  &#xD;
            7. Patients in whom the guidewire cannot pass through the lesion;&#xD;
  &#xD;
            8. Women who are pregnant or lactating;&#xD;
  &#xD;
            9. Patients who are participating in the clinical trial of other drugs or medical&#xD;
               devices;&#xD;
  &#xD;
           10. Other patients considered by the investigator to be unsuitable for this 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>
    <overall_contact>
      <last_name>Niu Siquan</last_name>
      <phone>(0371)61207777</phone>
      <email>siquanniu@sohu.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Seventh People's Hospital of Zhengzhou</name>
        <address>
          <city>Zhenzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Niu Siquan</last_name>
        <phone>(0371)61207777</phone>
        <email>siquanniu@sohu.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Renmin Hospital of Wuhan University Hubei General Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wang Jingping</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanxi Cardiovascular Hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yang Bo</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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 Stenosis</mesh_term>
      <mesh_term>Dilatation, Pathologic</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/NCT05998252
  org study id: S01
  nct id: NCT05998252
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, multi-center, single-group study aims to evaluate the safety and
        efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery
        stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI,
        and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up
        of the subjects will be recorded, and the safety and efficacy of the investigational device
        will be evaluated.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Procedural Success Rate
  time frame: 7 days
  description: Defined as meeting all the following criteria:
  After PCI, the target lesion achieves a final diameter stenosis of ≤30%, and the TIMI grade of 3;
  No all-cause mortality, Q-wave myocardial infarction, stroke, cardiac tamponade, or target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) during postoperative follow-up.
  measure: Device Success Rate
  time frame: 0 day
  description: Defined as meeting all the following criteria:
  Successful delivery to the target location, completely pre-dilatation and successful withdrawal by using Alveo HP Balloon Dilatation Catheter;
  No evidence of arterial perforation, flow-restricted dissection, decreased TIMI grade while using the device, or no clinically significant arrhythmias after pre-dilatation.
  measure: Device Performance Evaluation
  time frame: 0 day
  description: The investigators will evaluate the device performance according to the use and operation of the device during the procedure. Evaluate performance of balloon catheter delivery, inflation, deflation, and withdrawal, etc. There are 5 levels ranging from poor to excellent, higher scores indicate better performance.
  measure: Incidence of major adverse cardiac events (MACE) during the study.
  time frame: 0 - 7 days
  description: Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).
  measure: Adverse events and serious adverse events rate
  time frame: 0 - 7 days
  description: Adverse events and serious adverse events related to the study device during the study.
  measure: Other Adverse events and serious adverse events rate
  time frame: 0 - 7 days
  description: Occurrence of other adverse events and serious adverse events
  arm group label: Alveo balloon dilatation catheter
  arm group type: Experimental
  description: Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with Alveo balloon dilatation catheter.
  intervention type: Device
  intervention name: Alveo HP Balloon Dilatation Catheter
  description: Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.
  arm group label: Alveo balloon dilatation catheter
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Niu Siquan
  phone: (0371)61207777
  email: siquanniu@sohu.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Coronary Stenosis
  mesh term: Dilatation, Pathologic
  sharing ipd: No