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/NCT06029569</url>
    </required_header>
    <id_info>
      <org_study_id>BMA-AVF-DCB</org_study_id>
      <nct_id>NCT06029569</nct_id>
    </id_info>
    <brief_title>Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula</brief_title>
    <official_title>Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Bomaian Medical Technology Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Bomaian Medical Technology 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>
        Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the&#xD;
        treatment of dialysis pathway stenosis or blockage lesions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon&#xD;
        dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in&#xD;
        the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous&#xD;
        fistula in hemodialysis patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 15, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>6-month target lesion primary patency rate</measure>
      <time_frame>6months</time_frame>
      <description>Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Device success rate</measure>
      <time_frame>The day of operation.</time_frame>
      <description>The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical success rate</measure>
      <time_frame>7Days</time_frame>
      <description>The residual stenosis of the target lesion is ≤ 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical success rate</measure>
      <time_frame>1year</time_frame>
      <description>After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">256</enrollment>
    <condition>Peripheral Arterial Disease</condition>
    <arm_group>
      <arm_group_label>Rapamycin coated balloon dilation catheter for arteriovenous fistula</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Paclitaxel release high-pressure shunt balloon dilation catheter</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Rapamycin drug balloon angioplasty</intervention_name>
      <description>Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.</description>
      <arm_group_label>Paclitaxel release high-pressure shunt balloon dilation catheter</arm_group_label>
      <arm_group_label>Rapamycin coated balloon dilation catheter for arteriovenous fistula</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Paclitaxel drug balloon angioplasty</intervention_name>
      <description>Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.</description>
      <arm_group_label>Paclitaxel release high-pressure shunt balloon dilation catheter</arm_group_label>
      <arm_group_label>Rapamycin coated balloon dilation catheter for arteriovenous fistula</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. AVF has been established, with mature development and at least one successful&#xD;
               completion of hemodialysis；&#xD;
  &#xD;
            2. AVF has significant hemodynamic abnormalities；&#xD;
  &#xD;
          exclusion criteria&#xD;
  &#xD;
            1. The target lesion has undergone intervention treatment within 30 days；&#xD;
  &#xD;
            2. An intravascular stent has been placed at any location along the vascular pathway；&#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>qizhuang Jin</last_name>
      <phone>010-83572211</phone>
      <email>jinqizhuang@bjmu.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 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 8, 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>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Peripheral Vascular Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sirolimus</mesh_term>
      <mesh_term>Paclitaxel</mesh_term>
    </intervention_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/NCT06029569
  org study id: BMA-AVF-DCB
  nct id: NCT06029569
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the
        treatment of dialysis pathway stenosis or blockage lesions.
  To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon
        dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in
        the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous
        fistula in hemodialysis patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 6-month target lesion primary patency rate
  time frame: 6months
  description: Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.
  measure: Device success rate
  time frame: The day of operation.
  description: The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure.
  measure: Surgical success rate
  time frame: 7Days
  description: The residual stenosis of the target lesion is ≤ 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge.
  measure: Clinical success rate
  time frame: 1year
  description: After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before.
  arm group label: Rapamycin coated balloon dilation catheter for arteriovenous fistula
  arm group type: Experimental
  description: Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion
  arm group label: Paclitaxel release high-pressure shunt balloon dilation catheter
  arm group type: Sham Comparator
  description: Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group
  intervention type: Procedure
  intervention name: Rapamycin drug balloon angioplasty
  description: Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.
  arm group label: Paclitaxel release high-pressure shunt balloon dilation catheter
  arm group label: Rapamycin coated balloon dilation catheter for arteriovenous fistula
  intervention type: Procedure
  intervention name: Paclitaxel drug balloon angioplasty
  description: Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.
  arm group label: Paclitaxel release high-pressure shunt balloon dilation catheter
  arm group label: Rapamycin coated balloon dilation catheter for arteriovenous fistula
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: qizhuang Jin
  phone: 010-83572211
  email: jinqizhuang@bjmu.edu.cn
  responsible party type: Sponsor
  mesh term: Peripheral Arterial Disease
  mesh term: Peripheral Vascular Diseases
  mesh term: Sirolimus
  mesh term: Paclitaxel
  sharing ipd: No