<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/NCT03769623</url>
  </required_header>
  <id_info>
    <org_study_id>BIO-RISE CHINA</org_study_id>
    <nct_id>NCT03769623</nct_id>
  </id_info>
  <brief_title>A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease</brief_title>
  <acronym>Brave</acronym>
  <official_title>A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JW Medical Systems Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JW Medical Systems Ltd</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 a prospective, multicenter, randomized, blind, parallel and superiority test&#xD;
      study. It is planned to select 206 cases of subjects with small coronary artery vessel&#xD;
      disease who meet the inclusion/exclusion criteria. They are randomly divide them into&#xD;
      Biolimus release coronary balloon catheter treatment group and plain old balloon angioplasty&#xD;
      catheter (Powerline) treatment group according to the ratio of 1:1. All subjects accept&#xD;
      clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after&#xD;
      operation. Follow-up with angiography is conducted at 9 months. The late lumen loss in&#xD;
      diseased segment at 9 months after operation is the primary endpoint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was a prospective, multicenter, randomized, blind, parallel positive control, and&#xD;
      superiority test study, 206 subjects with small coronary artery disease who met the&#xD;
      inclusion/exclusion criteria were enrolled, subjects were randomly assigned to the treatment&#xD;
      group of Biolimus and Powerline at 1:1. All subjects underwent clinical follow-up at 30 days,&#xD;
      6 months, 9 months, and 12 months after surgery, and angiographic follow-up at 9 months. The&#xD;
      primary endpoint was late lumen loss at 9 months.&#xD;
&#xD;
      The study will enroll 206 subjects. The sample size determination process is as follows:&#xD;
&#xD;
      Sample size is calculated according to the primary endpoint, late lumen loss (LLL) in&#xD;
      diseased segment at 9 months after operation. Through literature review, a Meta analysis&#xD;
      combined 11 randomized and control study shows that the late lumen loss level of control&#xD;
      group (POBA) in the treatment of small vessel disease is 0.54mm. Another Meta analysis shows&#xD;
      that LLL after PTCA operation is 0.57±0.57mm. Clinical investigators and statisticians,&#xD;
      according to literature and clinical practice, suppose that the LLL level of test group (DCB)&#xD;
      in this study can be lowered to 0.32mm and the combined standard deviation of LLL of the two&#xD;
      groups is estimated to be 0.50mm conservatively.&#xD;
&#xD;
      The calculation formula of sample size for parallel design and superiority test is used. In&#xD;
      case of taking 0.025 at singles side for inspection level, taking 80% for power (1-β), and&#xD;
      taking 0 for superiority cut-off, conduct random grouping according to the ratio of 1:1, the&#xD;
      require sample size of each group is calculated to be 82 cases. Considering the maximum&#xD;
      failure rate 20% in angiography follow-up (as well as the early withdrawal and random damage&#xD;
      caused by other reasons), the planned total sample size of both groups is 206 cases finally,&#xD;
      including 103 cases for test group (DCB) and 103 cases for control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2019</start_date>
  <completion_date type="Actual">April 6, 2021</completion_date>
  <primary_completion_date type="Actual">February 20, 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>Diameter: 2.0mm, 2.25mm, 2.5mm, 2.75mm Length: 10mm, 15mm, 20mm, 25mm, 30mm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The late lumen loss</measure>
    <time_frame>9 months</time_frame>
    <description>The late lumen loss in the lesion segment 9 months after surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Biolimus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BA9 Drug-eluting Coronary Artery Balloon Catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Powerline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Balloon dilated catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biolimus</intervention_name>
    <description>103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus</description>
    <arm_group_label>Biolimus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Powerline</intervention_name>
    <description>103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline</description>
    <arm_group_label>Powerline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General inclusion criteria&#xD;
&#xD;
          1. Subjects with stable angina pectoris, unstable angina pectoris, old myocardial&#xD;
             infarction or silent myocardial ischemia with objective evidence;&#xD;
&#xD;
          2. Subjects at the age between ≥18 and ≤75 years old;&#xD;
&#xD;
          3. Subjects without contraindications of coronary revascularization (PCI or CABG);&#xD;
&#xD;
          4. Subjects are willing to participate in the study, sign informed consent form, and&#xD;
             accept angiography follow-up at 9 months after operation as well as clinical follow-up&#xD;
             after operation and at 30 days, 6 months, 9 months and 12 months after operation.&#xD;
&#xD;
        Radiography inclusion criteria&#xD;
&#xD;
          1. Target lesion is primary in-situ coronary artery disease, located on 1 or 2 different&#xD;
             coronary artery vessels, with no more than 1 target lesion on each coronary artery&#xD;
             vessel (in case of lesion on two vessels, 2 target lesions are allowed at most);&#xD;
&#xD;
          2. Reference vessel diameter is between 2.0 mm and 2.75 mm (visual observation);&#xD;
&#xD;
          3. For non-target vessel lesion, interventional therapy needs to be conducted firstly&#xD;
             (simultaneous therapy is required). After successful therapy, it is required to&#xD;
             conduct random and target lesion treatment;&#xD;
&#xD;
          4. Preoperative diameter stenosis must be ≥70% or ≥50%, accompanied with corresponding&#xD;
             ischemia of target vessel (visual observation);&#xD;
&#xD;
          5. Each target lesion of patients in test group and control group can only be treated&#xD;
             with one trial device (Biolimus release coronary balloon catheter) or control device&#xD;
             (Powerline balloon angioplasty catheter).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General exclusion criteria&#xD;
&#xD;
          1. Any patient with myocardial infarction within one month;&#xD;
&#xD;
          2. Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or&#xD;
             severe valvular heart disease;&#xD;
&#xD;
          3. Patients with cardiogenic shock;&#xD;
&#xD;
          4. Patients with left ventricular ejection fraction of less than 35%;&#xD;
&#xD;
          5. Female patients planned for or in pregnancy (or lactation) or male patients planned&#xD;
             for impregnation;&#xD;
&#xD;
          6. Patients with the expected lifetime of no more than 1 year or potential factors of&#xD;
             difficulty in clinical follow-up;&#xD;
&#xD;
          7. Patients who are participating in the clinical trial of other drug or device without&#xD;
             reaching the time limit of primary endpoint, or reaching the time limit of primary&#xD;
             endpoint but less than 3 months;&#xD;
&#xD;
          8. Patients who plans to accept selective operation within 12 months;&#xD;
&#xD;
          9. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper&#xD;
             limit of normal value), who are judged to be not applicable to angiography by&#xD;
             investigators;&#xD;
&#xD;
         10. Patients with severe renal failure(eGFR&lt;30ml/minute) or such medical history, failure&#xD;
             to comply with angiography conditions;&#xD;
&#xD;
         11. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6&#xD;
             months;&#xD;
&#xD;
         12. Patients with bleeding tendency or coagulation disorders;&#xD;
&#xD;
         13. Patients who are intolerance to aspirin and/or clopidogrel or ticagrelor or have&#xD;
             contraindications;&#xD;
&#xD;
         14. Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus,&#xD;
             polyethylene oxide and polylactic acid - glycolic acid polymer;&#xD;
&#xD;
         15. Patients with other diseases (for instance, malignant tumor, organ grafting or&#xD;
             candidate) or addiction history (such as alcohol, cocaine and heroin);&#xD;
&#xD;
         16. Subjects who are considered to be not applicable to be enrolled by investigators due&#xD;
             to other reasons.&#xD;
&#xD;
        Radiography exclusion criteria&#xD;
&#xD;
          1. Evidence for extensive thrombus within target vessel;&#xD;
&#xD;
          2. Chronic total occlusion (TIMI Level 0 blood flow before operation);&#xD;
&#xD;
          3. For the left main disease and/or triple vessel disease and bypass lesion needed to be&#xD;
             treated simultaneously, branch vessel diameter shall be ≥ 2.5mm bifurcation lesion;&#xD;
&#xD;
          4. Lesions within a distance of 3mm from circumflex branch, anterior descending branch&#xD;
             and right coronary artery orifice;&#xD;
&#xD;
          5. After treating other vascular lesions at the same period, there are more than two&#xD;
             lesions within the same target vessel needed to be treated;&#xD;
&#xD;
          6. There are more than 2 non-target lesions needed to be intervened or non-target lesion&#xD;
             is not intervened before target lesion;&#xD;
&#xD;
          7. There is target vessel distortion or severe calcification lesion, so balloon catheter&#xD;
             fails to pass it;&#xD;
&#xD;
          8. Target lesion is in-stent restenosis;&#xD;
&#xD;
          9. After predilation of target lesion, residual stenosis is ≥30% or TIMI blood flow is &lt;&#xD;
             Level 3, and/or there is NHBL Level C or above dissection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaling Han</last_name>
    <role>Principal Investigator</role>
    <affiliation>The General Hospital of Northern Theater Command</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital of Northern Theater Command</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>September 15, 2021</last_update_submitted>
  <last_update_submitted_qc>September 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</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>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT03769623
org study id: BIO-RISE CHINA
nct id: NCT03769623
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, multicenter, randomized, blind, parallel and superiority test
      study. It is planned to select 206 cases of subjects with small coronary artery vessel
      disease who meet the inclusion/exclusion criteria. They are randomly divide them into
      Biolimus release coronary balloon catheter treatment group and plain old balloon angioplasty
      catheter (Powerline) treatment group according to the ratio of 1:1. All subjects accept
      clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after
      operation. Follow-up with angiography is conducted at 9 months. The late lumen loss in
      diseased segment at 9 months after operation is the primary endpoint.
The study was a prospective, multicenter, randomized, blind, parallel positive control, and
      superiority test study, 206 subjects with small coronary artery disease who met the
      inclusion/exclusion criteria were enrolled, subjects were randomly assigned to the treatment
      group of Biolimus and Powerline at 1:1. All subjects underwent clinical follow-up at 30 days,
      6 months, 9 months, and 12 months after surgery, and angiographic follow-up at 9 months. The
      primary endpoint was late lumen loss at 9 months.

      The study will enroll 206 subjects. The sample size determination process is as follows:

      Sample size is calculated according to the primary endpoint, late lumen loss (LLL) in
      diseased segment at 9 months after operation. Through literature review, a Meta analysis
      combined 11 randomized and control study shows that the late lumen loss level of control
      group (POBA) in the treatment of small vessel disease is 0.54mm. Another Meta analysis shows
      that LLL after PTCA operation is 0.57±0.57mm. Clinical investigators and statisticians,
      according to literature and clinical practice, suppose that the LLL level of test group (DCB)
      in this study can be lowered to 0.32mm and the combined standard deviation of LLL of the two
      groups is estimated to be 0.50mm conservatively.

      The calculation formula of sample size for parallel design and superiority test is used. In
      case of taking 0.025 at singles side for inspection level, taking 80% for power (1-β), and
      taking 0 for superiority cut-off, conduct random grouping according to the ratio of 1:1, the
      require sample size of each group is calculated to be 82 cases. Considering the maximum
      failure rate 20% in angiography follow-up (as well as the early withdrawal and random damage
      caused by other reasons), the planned total sample size of both groups is 206 cases finally,
      including 103 cases for test group (DCB) and 103 cases for control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Diameter: 2.0mm, 2.25mm, 2.5mm, 2.75mm Length: 10mm, 15mm, 20mm, 25mm, 30mm
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The late lumen loss
time frame: 9 months
description: The late lumen loss in the lesion segment 9 months after surgery
arm group label: Biolimus
arm group type: Experimental
description: BA9 Drug-eluting Coronary Artery Balloon Catheter
arm group label: Powerline
arm group type: Active Comparator
description: Balloon dilated catheter
intervention type: Device
intervention name: Biolimus
description: 103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus
arm group label: Biolimus
intervention type: Device
intervention name: Powerline
description: 103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline
arm group label: Powerline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yaling Han
role: Principal Investigator
affiliation: The General Hospital of Northern Theater Command
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease