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/NCT05961852</url>
    </required_header>
    <id_info>
      <org_study_id>CONCERTO</org_study_id>
      <nct_id>NCT05961852</nct_id>
    </id_info>
    <brief_title>COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)</brief_title>
    <acronym>CONCERTO</acronym>
    <official_title>COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Singapore General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Medical Research Council (NMRC), Singapore</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Singapore General Hospital</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>
        To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for&#xD;
        the treatment of resistant AVF stenosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis&#xD;
        (defined as having &gt; 30% residual stenosis after optimal balloon angioplasty) to receive&#xD;
        cutting and drug-coated balloon.&#xD;
  &#xD;
        The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically&#xD;
        driven.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 15, 2018</start_date>
    <completion_date type="Actual">June 30, 2019</completion_date>
    <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
    <phase>Phase 1</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>Target lesion primary patency</measure>
      <time_frame>6 months after index procedure</time_frame>
      <description>Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">19</enrollment>
    <condition>Arteriovenous Fistula Stenosis</condition>
    <arm_group>
      <arm_group_label>Treatment arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cutting and drug-coated balloon angioplasty</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Angioplasty</intervention_name>
      <description>Angioplasty with cutting and drug-coated balloon</description>
      <arm_group_label>Treatment arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Failing mature upper limb AVF&#xD;
  &#xD;
            2. Resistant stenosis (&gt;30% residual stenosis) after optimal conventional balloon&#xD;
               angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at&#xD;
               least twice for at least a minute per inflation)&#xD;
  &#xD;
            3. Patient is &gt;= 21 years of age&#xD;
  &#xD;
            4. Ability to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Thrombosed AVF&#xD;
  &#xD;
            2. Target lesion has a sharp angle (&gt; 45 degrees)&#xD;
  &#xD;
            3. Lesions requiring cutting balloon size &gt; 7 mm&#xD;
  &#xD;
            4. Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure&#xD;
  &#xD;
            5. Contraindication to dual antiplatelet therapy&#xD;
  &#xD;
            6. Severe allergy to contrast media that cannot be adequately managed for the procedure&#xD;
  &#xD;
            7. Breast-feeding and/or pregnant females&#xD;
  &#xD;
            8. Male patients who are planning to father children during the trial period&#xD;
  &#xD;
            9. Unable to comply with follow up protocol (for instance, limited life expectancy)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kun Da Zhuang, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Singapore General Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Singapore General Hospital</name>
        <address>
          <city>Singapore</city>
          <zip>168609</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <reference>
      <citation>Wu CC, Lin MC, Pu SY, Tsai KC, Wen SC. Comparison of cutting balloon versus high-pressure balloon angioplasty for resistant venous stenoses of native hemodialysis fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):877-83. doi: 10.1016/j.jvir.2008.02.016. Epub 2008 May 2.</citation>
      <PMID>18503902</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 17, 2023</last_update_submitted>
    <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>arteriovenous fistula</keyword>
    <keyword>drug-coated balloon</keyword>
    <keyword>cutting balloon</keyword>
    <keyword>stenosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arteriovenous Fistula</mesh_term>
      <mesh_term>Constriction, Pathologic</mesh_term>
      <mesh_term>Fistula</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05961852
  org study id: CONCERTO
  nct id: NCT05961852
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for
        the treatment of resistant AVF stenosis.
  This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis
        (defined as having > 30% residual stenosis after optimal balloon angioplasty) to receive
        cutting and drug-coated balloon.
  
        The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically
        driven.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Target lesion primary patency
  time frame: 6 months after index procedure
  description: Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.
  arm group label: Treatment arm
  arm group type: Experimental
  description: Cutting and drug-coated balloon angioplasty
  intervention type: Device
  intervention name: Angioplasty
  description: Angioplasty with cutting and drug-coated balloon
  arm group label: Treatment arm
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kun Da Zhuang, MBBS
  role: Principal Investigator
  affiliation: Singapore General Hospital
  facility: 
  country: Singapore
  citation: Wu CC, Lin MC, Pu SY, Tsai KC, Wen SC. Comparison of cutting balloon versus high-pressure balloon angioplasty for resistant venous stenoses of native hemodialysis fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):877-83. doi: 10.1016/j.jvir.2008.02.016. Epub 2008 May 2.
  PMID: 18503902
  responsible party type: Sponsor
  mesh term: Arteriovenous Fistula
  mesh term: Constriction, Pathologic
  mesh term: Fistula
  sharing ipd: Undecided