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/NCT06024525</url>
    </required_header>
    <id_info>
      <org_study_id>DP01-048B</org_study_id>
      <nct_id>NCT06024525</nct_id>
    </id_info>
    <brief_title>Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®</brief_title>
    <official_title>Prospective, Multi-center Non-inferiority and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Shenqi Medical Technology Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Shenqi 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 assess the safety and efficacy of the Paclitaxel-Coated&#xD;
        Coronary Balloon Catheters Swide® (3µg/mm2 balloon surface area) in the treatment of Chinese&#xD;
        patients with native coronary heart disease and small vessel lesions（reference diameters from&#xD;
        2.0mm to 2.75 mm） in comparison with Paclitaxel-Releasing Coronary Balloon Catheter SeQuent®&#xD;
        please Neo&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study conducted a prospective, multi-center, randomized controlled, non-inferiority&#xD;
        clinical trial to compare the safety and efficacy of the Shenqi Medical paclitaxel-coated&#xD;
        coronary balloon catheter and the paclitaxel-eluting coronary balloon catheter (SeQuent®&#xD;
        please Neo) in the treatment of coronary artery small vascular disease.&#xD;
  &#xD;
          -  A total of 236 participants are planned to be recruited, and they will be allocated into&#xD;
             the experimental group and the control group in a 1:1 ratio.&#xD;
  &#xD;
          -  All participants will undergo clinical follow-up at 1 month, 6 months, 9 months, 1 year,&#xD;
             and 2 years after receiving the drug-eluting balloon angioplasty procedure.&#xD;
  &#xD;
          -  Angiographic re-evaluation will be conducted for all participants at 9 months after the&#xD;
             procedure. The primary study endpoint will be the in-segment diameter stenosis in target&#xD;
             lesion(%) at 9 months postoperatively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">June 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</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>Single (Outcomes Assessor)</masking>
      <masking_description>The use of a third-party independent CEC and an independent coronary angiography core laboratory to adjudicate each primary and other endpoints helps reduce measurement bias from outcome measures.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>In-segment diameter stenosis in target lesion(%).</measure>
      <time_frame>9 months</time_frame>
      <description>DS% = (1 - minimum luminal diameter within the target lesion segment / reference diameter within the target lesion segment) × 100%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Technical success rate</measure>
      <time_frame>Immediate postoperative</time_frame>
      <description>defined as the successful arrival of the device to the target lesion, successful dilation, and smooth withdrawal, without the use of any additional interventional treatment methods, with residual stenosis ≤30% (estimated method), TIMI blood flow grade 3, and no grade C or higher dissection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lesion success rate</measure>
      <time_frame>Immediate postoperative</time_frame>
      <description>defined as residual stenosis within the target lesion segment being ≤30% (estimated method) after using any interventional treatment method, with TIMI blood flow grade 3 and no grade C or higher dissection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedural success rate</measure>
      <time_frame>during the hospitalization and no more 7 days</time_frame>
      <description>defined as the absence of device-related composite endpoint events during the hospitalization period on the basis of lesion success rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects with target lesion failure.</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
      <description>defined as the composite endpoint of cardiac death, target vessel-related myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR);</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects with patient-related composite endpoints</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
      <description>defined as the composite endpoint of all-cause death, all myocardial infarctions, and any revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Subjects' mortality</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Subjects' myocardial infarction</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Subjects' target lesion revascularization</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Subjects' any coronary revascularization</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Subjects with Thrombotic Events as defined by ARC</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
      <description>includes definite, probable, and unexcluded thrombus in the acute, subacute, late, and late late timeframes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence Rate of All AE and SAE in subjects</measure>
      <time_frame>in month-1, 6, 9, 12 ,24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Late Lumen Loss</measure>
      <time_frame>9 months</time_frame>
      <description>defined as the change in minimal lumen diameter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of target lesion restenosis</measure>
      <time_frame>9 months</time_frame>
      <description>proportion of patients with &gt;50% diameter stenosis</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">236</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Paclitaxel-Coated Coronary Balloon Catheters</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>receiving the treatment with Swide®DCB in small vessel cohort</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Paclitaxel-Releasing Coronary Balloon Catheter</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>receiving the treatment with SeQuent® please Neo in small vessel cohort</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Paclitaxel-Coated Coronary Balloon Catheters</intervention_name>
      <description>to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients</description>
      <arm_group_label>Paclitaxel-Coated Coronary Balloon Catheters</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Paclitaxel-Releasing Coronary Balloon Catheters</intervention_name>
      <description>to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients</description>
      <arm_group_label>Paclitaxel-Releasing Coronary Balloon Catheter</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Related to the patients:&#xD;
  &#xD;
            1. Age ≥18 and ≤80 years old；&#xD;
  &#xD;
            2. Subjects with stable angina, or with unstable angina, or with subacute, old myocardial&#xD;
               infarction, or evidence of asymptomatic ischemia；&#xD;
  &#xD;
            3. Subjects with left ventricular ejection fraction ≥ 30%;&#xD;
  &#xD;
            4. During the study, women of childbearing age should not become pregnant or plan to&#xD;
               become pregnant. Therefore, it is recommended that subjects use adequate contraceptive&#xD;
               measures until (including) the end of the follow-up period；&#xD;
  &#xD;
            5. Subjects should have sufficient compliance and agree to receive follow-ups in month-1,&#xD;
               6, 9 and 12, and follow-up visit in year-2. It is required to perform angiography in 9&#xD;
               month；&#xD;
  &#xD;
            6. Subjects should volunteer to participate in this study, and sign the written informed&#xD;
               consent form, and understand all risks and benefits in the informed consent document.&#xD;
  &#xD;
               Related to the diseases:&#xD;
  &#xD;
            7. The target lesion is primary, in situ coronary artery lesion, located on 1 or 2&#xD;
               different coronary vessels, and the number of target lesions on each coronary vessel&#xD;
               does not exceed 1；&#xD;
  &#xD;
            8. Reference vessel diameter between 2.0 mm and 2.75 mm；&#xD;
  &#xD;
            9. Non-target vascular lesions need to be treated with interventional therapy first (must&#xD;
               be treated at the same time), after successful treatment, random and target lesions&#xD;
               will be treated;&#xD;
  &#xD;
           10. Preoperative diameter stenosis must be ≥70% or ≥50% with ischemia; (visual inspection)&#xD;
  &#xD;
           11. Each target lesion can only be treated with one experimental drug balloon;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with myocardial infarction within one week, or subjects whose troponin has&#xD;
               not returned to normal despite the onset of myocardial infarction for more than one&#xD;
               week;&#xD;
  &#xD;
            2. Subjects with severe congestive heart failure or NYHA IV heart failure;&#xD;
  &#xD;
            3. Women who are pregnant or breastfeeding;&#xD;
  &#xD;
            4. Subjects whose life expectancy does not exceed 1 year or who have factors that make&#xD;
               clinical follow-up difficult;&#xD;
  &#xD;
            5. Subjects with stroke within 6 months;&#xD;
  &#xD;
            6. Subjects who are participating in any other clinical trials and have not reached the&#xD;
               primary clinical endpoint;&#xD;
  &#xD;
            7. Existing or history of severe liver failure, therefore not eligible for angiography;&#xD;
  &#xD;
            8. Existing or history of severe renal failure (GFR&lt;30ml/min), therefore not eligible for&#xD;
               angiography;&#xD;
  &#xD;
            9. Heart transplant;&#xD;
  &#xD;
           10. Cardiogenic shock;&#xD;
  &#xD;
           11. Coronary artery spasm without significant stenosis;&#xD;
  &#xD;
           12. The researchers think that the subjects are not suitable for others inclusion reason;&#xD;
  &#xD;
           13. Evidence of extensive thrombus in the target vessel before intervention;&#xD;
  &#xD;
           14. Coronary artery bypass grafting using vein grafts;&#xD;
  &#xD;
           15. Complete occlusion of the target vessel (TIMI grade 0 blood flow before operation)&#xD;
  &#xD;
           16. Target vessels are distorted or have calcified lesions that cannot be pre-dilated&#xD;
               successfully;&#xD;
  &#xD;
           17. Lesions within 5 mm from the coronary artery ostia;&#xD;
  &#xD;
           18. Lesions that cannot be treated with PTCA or other interventional techniques;&#xD;
  &#xD;
           19. After pre-dilation of the target lesion, residual stenosis &gt; 50% or TIMI blood flow &lt;&#xD;
               grade 3, and/or type C or above dissection;&#xD;
  &#xD;
           20. Subjects with bleeding constitution, contraindicated anticoagulant or antiplatelet&#xD;
               drugs;&#xD;
  &#xD;
           21. Subjects who cannot tolerate aspirin and/or clopidogrel or have a history of&#xD;
               neutropenia or thrombocytopenia, or severe liver insufficiency that prohibits&#xD;
               clopidogrel;&#xD;
  &#xD;
           22. Subjects who are known to be intolerant or allergic to heparin, contrast medium,&#xD;
               paclitaxel, iopromide, polylactic acid-glycolic acid polymer, stainless steel, etc.;&#xD;
  &#xD;
           23. Leukopenia (white blood cell count &lt;3×109/L for more than 3 days) or neutropenia&#xD;
               (ANC&lt;1000 neutrophils/mm3 for more than 3 days) or history of thrombocytopenia&#xD;
               (&lt;100,000 platelets/mm3) subjects;&#xD;
  &#xD;
           24. Subjects with a history of peptic ulcer or gastrointestinal bleeding in the past 6&#xD;
               months;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>chaojun gu</last_name>
      <phone>+86-13636491192</phone>
      <email>chaojun.gu@sqmedical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Meizhou People's Hospital (Huangtang Hospital, Meizhou Academy of Medical Sciences)</name>
        <address>
          <city>Meizhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>ZHIXIONG ZHONG</last_name>
        <phone>+86 753 213 1363</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    </intervention_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/NCT06024525
  org study id: DP01-048B
  nct id: NCT06024525
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to assess the safety and efficacy of the Paclitaxel-Coated
        Coronary Balloon Catheters Swide® (3µg/mm2 balloon surface area) in the treatment of Chinese
        patients with native coronary heart disease and small vessel lesions（reference diameters from
        2.0mm to 2.75 mm） in comparison with Paclitaxel-Releasing Coronary Balloon Catheter SeQuent®
        please Neo
  This study conducted a prospective, multi-center, randomized controlled, non-inferiority
        clinical trial to compare the safety and efficacy of the Shenqi Medical paclitaxel-coated
        coronary balloon catheter and the paclitaxel-eluting coronary balloon catheter (SeQuent®
        please Neo) in the treatment of coronary artery small vascular disease.
  
          -  A total of 236 participants are planned to be recruited, and they will be allocated into
             the experimental group and the control group in a 1:1 ratio.
  
          -  All participants will undergo clinical follow-up at 1 month, 6 months, 9 months, 1 year,
             and 2 years after receiving the drug-eluting balloon angioplasty procedure.
  
          -  Angiographic re-evaluation will be conducted for all participants at 9 months after the
             procedure. The primary study endpoint will be the in-segment diameter stenosis in target
             lesion(%) at 9 months postoperatively.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The use of a third-party independent CEC and an independent coronary angiography core laboratory to adjudicate each primary and other endpoints helps reduce measurement bias from outcome measures.
  measure: In-segment diameter stenosis in target lesion(%).
  time frame: 9 months
  description: DS% = (1 - minimum luminal diameter within the target lesion segment / reference diameter within the target lesion segment) × 100%.
  measure: Technical success rate
  time frame: Immediate postoperative
  description: defined as the successful arrival of the device to the target lesion, successful dilation, and smooth withdrawal, without the use of any additional interventional treatment methods, with residual stenosis ≤30% (estimated method), TIMI blood flow grade 3, and no grade C or higher dissection.
  measure: Lesion success rate
  time frame: Immediate postoperative
  description: defined as residual stenosis within the target lesion segment being ≤30% (estimated method) after using any interventional treatment method, with TIMI blood flow grade 3 and no grade C or higher dissection.
  measure: Procedural success rate
  time frame: during the hospitalization and no more 7 days
  description: defined as the absence of device-related composite endpoint events during the hospitalization period on the basis of lesion success rate
  measure: The proportion of subjects with target lesion failure.
  time frame: in month-1, 6, 9, 12 ,24
  description: defined as the composite endpoint of cardiac death, target vessel-related myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR);
  measure: The proportion of subjects with patient-related composite endpoints
  time frame: in month-1, 6, 9, 12 ,24
  description: defined as the composite endpoint of all-cause death, all myocardial infarctions, and any revascularization
  measure: Proportion of Subjects' mortality
  time frame: in month-1, 6, 9, 12 ,24
  measure: Proportion of Subjects' myocardial infarction
  time frame: in month-1, 6, 9, 12 ,24
  measure: Proportion of Subjects' target lesion revascularization
  time frame: in month-1, 6, 9, 12 ,24
  measure: Proportion of Subjects' any coronary revascularization
  time frame: in month-1, 6, 9, 12 ,24
  measure: Proportion of Subjects with Thrombotic Events as defined by ARC
  time frame: in month-1, 6, 9, 12 ,24
  description: includes definite, probable, and unexcluded thrombus in the acute, subacute, late, and late late timeframes
  measure: Incidence Rate of All AE and SAE in subjects
  time frame: in month-1, 6, 9, 12 ,24
  measure: Late Lumen Loss
  time frame: 9 months
  description: defined as the change in minimal lumen diameter
  measure: Incidence of target lesion restenosis
  time frame: 9 months
  description: proportion of patients with >50% diameter stenosis
  arm group label: Paclitaxel-Coated Coronary Balloon Catheters
  arm group type: Experimental
  description: receiving the treatment with Swide®DCB in small vessel cohort
  arm group label: Paclitaxel-Releasing Coronary Balloon Catheter
  arm group type: Active Comparator
  description: receiving the treatment with SeQuent® please Neo in small vessel cohort
  intervention type: Device
  intervention name: Paclitaxel-Coated Coronary Balloon Catheters
  description: to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients
  arm group label: Paclitaxel-Coated Coronary Balloon Catheters
  intervention type: Device
  intervention name: Paclitaxel-Releasing Coronary Balloon Catheters
  description: to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients
  arm group label: Paclitaxel-Releasing Coronary Balloon Catheter
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: chaojun gu
  phone: +86-13636491192
  email: chaojun.gu@sqmedical.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Paclitaxel
  mesh term: Albumin-Bound Paclitaxel