<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/NCT03817801</url>
  </required_header>
  <id_info>
    <org_study_id>NFH20190104</org_study_id>
    <nct_id>NCT03817801</nct_id>
  </id_info>
  <brief_title>Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk</brief_title>
  <acronym>PREPARE-NSE</acronym>
  <official_title>Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk: A Randomized, Single-center, Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is designed to investigate whether scoring balloon (non-slip element, NSE)&#xD;
      predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients&#xD;
      with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead&#xD;
      to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study that aim to enroll 60 subjects with high bleeding risk.&#xD;
&#xD;
      All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1&#xD;
      randomization either to NSE predilation or NC balloon predilation using a randomization&#xD;
      schedule.&#xD;
&#xD;
      All subjects will be screened according to the predefined inclusion and exclusion criteria&#xD;
      per protocol and will further undergo IVUS before DCB treatment. Data and images will be&#xD;
      collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2019</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</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>
    <intervention_model_description>Patients will undergo 1:1 randomization to either non-slip element (NSE) predilation which will be the treatment group or non-compliant (NC) balloon predilation which will be the control group. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1and 6 months after the index procedure.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor will remain blinded until the final study results are released.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The absolute change in minimal lumen area (MLA)</measure>
    <time_frame>6 months</time_frame>
    <description>The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bailout drug-eluting stents (DES) implantation rate</measure>
    <time_frame>During procedure</time_frame>
    <description>Bailout DES implantation rate during procedure by angiographic criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional Flow Reserve (FFR) value</measure>
    <time_frame>immediately after balloon predilation</time_frame>
    <description>FFR value after balloon predilation measured by FFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum lumen area (MLA)</measure>
    <time_frame>immediately after procedure</time_frame>
    <description>MLA after procedure by IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum lumen diameter (MLD)</measure>
    <time_frame>immediately after procedure</time_frame>
    <description>MLD after procedure by IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque burden</measure>
    <time_frame>immediately after procedure</time_frame>
    <description>Plaque burden after procedure by IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dissection</measure>
    <time_frame>immediately after procedure</time_frame>
    <description>Dissection after procedure by IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atheroma volume</measure>
    <time_frame>immediately after procedure</time_frame>
    <description>Atheroma volume after procedure by IVUS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The diameter stenosis of target lesion</measure>
    <time_frame>6 months</time_frame>
    <description>The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The late lumen loss of target lesion</measure>
    <time_frame>6 months</time_frame>
    <description>The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The binary restenosis of target lesion</measure>
    <time_frame>6 months</time_frame>
    <description>The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis</measure>
    <time_frame>6 months</time_frame>
    <description>The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>non-slip element (NSE) predilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-compliant (NC) balloon predilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NSE balloon</intervention_name>
    <description>NSE (Goodman®) predilation + DCB (Sequent® Please) treatment</description>
    <arm_group_label>non-slip element (NSE) predilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NC balloon</intervention_name>
    <description>NC balloon predilation + DCB (Sequent® Please) treatment</description>
    <arm_group_label>non-compliant (NC) balloon predilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow&#xD;
             reserve (FFR) test;&#xD;
&#xD;
          -  Coronary artery disease (CAD) patients with high risk of bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous coronary artery bypass graft (CABG) patients&#xD;
&#xD;
          -  Stent implantation in the target vessel&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt; 30 ml/min/1.73m2&#xD;
&#xD;
          -  Acute ST segment elevation myocardial infarction (STEMI) within 48 hours&#xD;
&#xD;
          -  Contraindications to contrast media, antiplatelet therapy, or paclitaxel&#xD;
&#xD;
          -  Cardiac shock&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Expected life less than 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shao-Liang Chen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>April 24, 2022</last_update_submitted>
  <last_update_submitted_qc>April 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing First Hospital, Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Junjie Zhang</investigator_full_name>
    <investigator_title>Vice Director of Cardiovascular Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03817801
org study id: NFH20190104
nct id: NCT03817801
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is designed to investigate whether scoring balloon (non-slip element, NSE)
      predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients
      with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead
      to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).
This is a pilot study that aim to enroll 60 subjects with high bleeding risk.

      All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1
      randomization either to NSE predilation or NC balloon predilation using a randomization
      schedule.

      All subjects will be screened according to the predefined inclusion and exclusion criteria
      per protocol and will further undergo IVUS before DCB treatment. Data and images will be
      collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will undergo 1:1 randomization to either non-slip element (NSE) predilation which will be the treatment group or non-compliant (NC) balloon predilation which will be the control group. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1and 6 months after the index procedure.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessor will remain blinded until the final study results are released.
measure: The absolute change in minimal lumen area (MLA)
time frame: 6 months
description: The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)
measure: Bailout drug-eluting stents (DES) implantation rate
time frame: During procedure
description: Bailout DES implantation rate during procedure by angiographic criteria
measure: Fractional Flow Reserve (FFR) value
time frame: immediately after balloon predilation
description: FFR value after balloon predilation measured by FFR
measure: Minimum lumen area (MLA)
time frame: immediately after procedure
description: MLA after procedure by IVUS
measure: Minimum lumen diameter (MLD)
time frame: immediately after procedure
description: MLD after procedure by IVUS
measure: Plaque burden
time frame: immediately after procedure
description: Plaque burden after procedure by IVUS
measure: Dissection
time frame: immediately after procedure
description: Dissection after procedure by IVUS
measure: Atheroma volume
time frame: immediately after procedure
description: Atheroma volume after procedure by IVUS
measure: The diameter stenosis of target lesion
time frame: 6 months
description: The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography
measure: The late lumen loss of target lesion
time frame: 6 months
description: The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography
measure: The binary restenosis of target lesion
time frame: 6 months
description: The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography
measure: The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis
time frame: 6 months
description: The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months.
arm group label: non-slip element (NSE) predilation
arm group type: Experimental
description: In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment.
arm group label: non-compliant (NC) balloon predilation
arm group type: Active Comparator
description: In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment.
intervention type: Device
intervention name: NSE balloon
description: NSE (Goodman®) predilation + DCB (Sequent® Please) treatment
arm group label: non-slip element (NSE) predilation
intervention type: Device
intervention name: NC balloon
description: NC balloon predilation + DCB (Sequent® Please) treatment
arm group label: non-compliant (NC) balloon predilation
criteria: 
gender: All
minimum age: N/A
maximum age: 80 Years
healthy volunteers: No
last name: Shao-Liang Chen, MD, PhD
role: Study Chair
affiliation: Nanjing First Hospital, Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing First Hospital, Nanjing Medical University
investigator full name: Junjie Zhang
investigator title: Vice Director of Cardiovascular Department
mesh term: Coronary Artery Disease
sharing ipd: No