<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/NCT03820622</url>
  </required_header>
  <id_info>
    <org_study_id>DIOR 2nd -1706</org_study_id>
    <nct_id>NCT03820622</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions</brief_title>
  <acronym>BEYOND-II</acronym>
  <official_title>Comparison of the Safety and Efficacy Between Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) and Paclitaxel-Eluting Balloon (Bingo) in Coronary Bifurcation Lesions: A Prospective, Multicenter, Randomized, Controlled Trial (BEYOND II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CCRF Inc., Beijing, China</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CCRF Inc., Beijing, China</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>
      To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon&#xD;
      dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with&#xD;
      paclitaxel-eluting balloon (Bingo), and to provide the clinical data for the formal&#xD;
      application in China and for the approvement of China marketing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, randomize, control and non-inferior study. 220 patients&#xD;
      with bifurcation lesions will be randomized 1:1 to each group. after the main branch has been&#xD;
      treated successfully, and if the side branch's stenosis is more than 70% and can be&#xD;
      pre-dilated by POBA (plain old balloon angioplasty) successfully, then randomizing. the&#xD;
      patients in the study group will be treated with paclitaxel-eluting coronary artery balloon&#xD;
      dilatation catheter (DIOR), while those in the control group will be treated with&#xD;
      paclitaxel-eluting balloon (Bingo). Clinical follow-up will be conducted at baseline,&#xD;
      operation, hospital discharge, 1 month, 6 months, 9 months and 12 months after operation, and&#xD;
      angiographic follow-up will be conducted at 9 months. The primary endpoint is late lumen loss&#xD;
      (LLL) in the balloon dilatation coverage area of side branch of at 9 month after operation.&#xD;
      The secondary endpoints include device success, clinical success, target lesion failure&#xD;
      (TLF), target lesion revascularization (TLR), clinical composite endpoints and imaging&#xD;
      endpoints. The information of adverse events, serious adverse events and device defects will&#xD;
      be collected during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2022</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>late lumen loss</measure>
    <time_frame>9 months after operation</time_frame>
    <description>in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>device success</measure>
    <time_frame>immediately post procedure</time_frame>
    <description>define as dilation success in the side branch lesion by study balloon or control ballon, that is the residual stenosis ≤50%，TIMI (Thrombolysis In Myocardial Infarction) 3 flow and without type C or above dissection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical success</measure>
    <time_frame>1 month after operation</time_frame>
    <description>define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>device oriented composite endpoints (DoCE)</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
    <description>that is TLF, define as the composite endpoint include cardiac death, target vessel myocardial infarction and ischemic driven target lesion revascularization (ID-TLR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients oriented composite endpoints (PoCE)</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
    <description>define as a composite endpoints of all cause death, any myocardial infarction and any revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all cause death</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
    <description>include cardiac death, vascular death, noncardiovascular death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction (MI)</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
    <description>target vessel MI, non-target vessel MI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>target lesion revasculation</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
    <description>ischemic driven, non-ischemic driven</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>target vessel revasculation</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
    <description>ischemic driven, non-ischemic driven</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>any coronary revasculation</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>thrombosis in the side branch lesion</measure>
    <time_frame>1, 6, 9, 12 month after operation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>angiographic endpoints-late loss of side branch</measure>
    <time_frame>9 months after operation</time_frame>
    <description>assess in millimeter</description>
  </other_outcome>
  <other_outcome>
    <measure>angiographic endpoints-minimal lumen diameter (MLD) of side branch</measure>
    <time_frame>9 months after operation</time_frame>
    <description>assess in millimeter</description>
  </other_outcome>
  <other_outcome>
    <measure>angiographic endpoints-diameter stenosis (DS)</measure>
    <time_frame>9 months after operation</time_frame>
    <description>assess in percentage</description>
  </other_outcome>
  <other_outcome>
    <measure>angiographic endpoints-angiographic binary restenosis (ABR)</measure>
    <time_frame>9 months after operation</time_frame>
    <description>assess in percentage</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>DIOR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in this group, patients will be treated with Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bingo group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in this group, patients will be treated with Paclitaxel-Eluting Balloon (Bingo)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)</intervention_name>
    <description>patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)</description>
    <arm_group_label>DIOR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paclitaxel-Eluting Balloon (Bingo)</intervention_name>
    <description>patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)</description>
    <arm_group_label>Bingo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects that participate in this study must fulfill all the following criteria:&#xD;
&#xD;
        General inclusion criteria:&#xD;
&#xD;
          1. Age from 18 to 80 years old, man or non-pregnant woman;&#xD;
&#xD;
          2. Subjects with stable or unstable angina, old myocardial infarction, or asymptomatic&#xD;
             ischemic evidence with clinical diagnosis;&#xD;
&#xD;
          3. Subjects without contraindications of coronary artery bypass grafting (CABG);&#xD;
&#xD;
          4. Subjects must agree to the follow up of angiographic and clinical required in the&#xD;
             study;&#xD;
&#xD;
          5. Subjects are able to understand the purpose of this study, provide an informed consent&#xD;
             to show recognize to the study protocol.&#xD;
&#xD;
        Angiographic inclusion criteria:&#xD;
&#xD;
          1. One or two bifurcation lesions, locate in different epicardial vessels, the&#xD;
             bifurcation lesion in each epicardial vessel can not over 1; or 1 de nove coronary&#xD;
             artery bifurcation can be included after 1 lesion of non-target vessel has been&#xD;
             successfully treated by PCI (Percutaneous Coronary Intervention);&#xD;
&#xD;
          2. Residual diameter stenosis in main branch (MB) ≥ 70% (visually), or ≥ 50%&#xD;
             simultaneously with clinical symptom, and the diameter stenosis in side branch (SB) ≥&#xD;
             50% (visually); and the main branch's residual stenosis ≤ 20% with TIMI 3 flow post&#xD;
             the stent placement, while the side branch diameter stenosis ≥ 70% post the MB&#xD;
             stenting;&#xD;
&#xD;
          3. Fulfill the definition of truly bifurcation lesions by Medina type&#xD;
             (1.1.1、1.0.1、0.1.1);&#xD;
&#xD;
          4. Diameter in side branch between ≥ 2.5 mm to ≤ 4.00 mm (visually) and lesion length ≤&#xD;
             26 mm (visually);&#xD;
&#xD;
          5. Each side branch of the bifurcation lesion can be treated by only 1 study drug coated&#xD;
             balloon (DCB) or control DCB, and the lesion shall be fully covered by the DCB ( the&#xD;
             distal end of the balloon shall exceed the lesion at least 1 mm).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        If subjects fulfill any of below criteria, this subject shall be exclude from this study.&#xD;
&#xD;
        General exclusion criteria:&#xD;
&#xD;
          1. Pregnant or lactating women&#xD;
&#xD;
          2. Any newly myocardial infarction onset within 1 week or, the myocardial enzyme of CK&#xD;
             (Creatine Kinase) or CK-MB does not return to normal level after any myocardial&#xD;
             infarction;&#xD;
&#xD;
          3. Cardiogenic shock;&#xD;
&#xD;
          4. Severe chronic heart failure, NYHA (New York Heart Association) ≥ grade III, or left&#xD;
             ventricular ejection fraction &lt; 35% (accessed by echocardiography or left ventricular&#xD;
             angiography)&#xD;
&#xD;
          5. Patients with renal insufficiency (estimated glomerular filtration rate &lt;&#xD;
             30ml/min/1.73m2 calculated by MRDR (Modification of Diet in Renal Disease) formula or&#xD;
             subject is receiving renal dialysis)&#xD;
&#xD;
          6. Having a history of hemorrhagic diseases such as cerebral hemorrhage, gastrointestinal&#xD;
             hemorrhage; stroke occurring or any situation occurring that may lead to prolongation&#xD;
             of anticoagulation therapy within 6 months before operation;&#xD;
&#xD;
          7. History of coronary or peripheral vascular interventional therapy within 12 months&#xD;
             before hospitalized.&#xD;
&#xD;
          8. Patients are allergic or contraindicate to contrast agent, paclitaxel, heparin,&#xD;
             antiplatelet and anticoagulant drug;&#xD;
&#xD;
          9. The Subjects have other serious diseases and the expected survival is less than 12&#xD;
             months;&#xD;
&#xD;
         10. Investigators determine the subjects' compliance is poor, cannot complete the study as&#xD;
             required;&#xD;
&#xD;
        Angiographic exclusion criteria&#xD;
&#xD;
          1. Main branch lesion or non-target lesion(s) located in left main;&#xD;
&#xD;
          2. Main branch lesion or non-target lesion(s) is triple vessel lesion, all need to be&#xD;
             treated;&#xD;
&#xD;
          3. Side branch lesion is triple bifurcation or multiple bifurcation;&#xD;
&#xD;
          4. Main branch lesion located within 3 mm of the origin of the LAD (Left Anterior&#xD;
             Descending), LCX (Left Circumflex Branch) or RCA (Right Coronary Arter);&#xD;
&#xD;
          5. Side branch target lesion is diffusion lesion and length &gt; 26mm; or a ≥90% stenosis&#xD;
             lesion is found near the SB lesion within 5 mm;&#xD;
&#xD;
          6. Side branch as the target vessel has received any interventional treatment;&#xD;
&#xD;
          7. Side branch as the target lesion or target vessel involve in aneurysm;&#xD;
&#xD;
          8. The lesion in side branch or main branch is total occlusive lesions, with TIMI blood&#xD;
             flow of grade 0;&#xD;
&#xD;
          9. Side branch target lesion is moderate or heavy calcified or target vessel excessive&#xD;
             tortuosity, which is unfavorable for interventional treatment anatomically;&#xD;
&#xD;
         10. Subject's blood pressure is too low to be injected with nitroglycerin ≥ 100 ug, this&#xD;
             subject can not be included in the study;&#xD;
&#xD;
         11. Side branch target lesion can not reach the following outcomes, after the completely&#xD;
             balloon pre-dilatation:&#xD;
&#xD;
        1) Residual stenosis (DS %) is ≤50% (visually); 2) TIMI Grade-3 flow ((visually); 3) No&#xD;
        angiographic complications (e.g., no-reflow, distal embolization, side branch closure) 4)&#xD;
        No dissections NHLBI grade C-F;&#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_official>
    <last_name>Yaling Han, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The General Hospital of Northern Theater Command</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bing Wang, professor</last_name>
    <phone>86-024-28851120</phone>
    <email>wangbindl@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Geng Wang, professor</last_name>
    <phone>86-024-28851120</phone>
    <email>wanggeng69@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Daqing Oil General Hospital</name>
      <address>
        <city>Daqing</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hui Li, professor</last_name>
      <phone>86-0459-5805310</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Asian Heart Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xi Su, professor</last_name>
      <phone>86-027-65796888</phone>
      <email>yaxin_suxi@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Saoliang Chen, professor</last_name>
      <phone>86-025-52271351</phone>
      <email>chmengx@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Bethune Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Dalian University</name>
      <address>
        <city>Dalian</city>
        <state>Liaonin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Northern Theater Command</name>
      <address>
        <city>Shengyang</city>
        <state>Liaonin</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Han Yaling, professor</last_name>
      <phone>86-024-28851120</phone>
      <email>hanyaling@263.net</email>
    </contact>
    <contact_backup>
      <last_name>Geng wang, professor</last_name>
      <phone>86-024-28851120</phone>
      <email>wanggeng69@163.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shengyang</city>
        <state>Liaonin</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yingxian Sun</last_name>
      <phone>86-024-83283166</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Guosheng Fu, professor</last_name>
      <phone>86-0571-86090073</phone>
      <email>fugs@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wang jian'an, professor</last_name>
      <phone>86-0571-87783777</phone>
      <email>wangjianan@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital,</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Qi Zhang, professor</last_name>
      <phone>86-021-38804518</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Chest Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hongliang Cong, professor</last_name>
      <phone>86-022-88185003</phone>
      <email>hongliangcong@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coronary artery stenosis</keyword>
  <keyword>drug eluting balloon</keyword>
  <keyword>bifurcation</keyword>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03820622
org study id: DIOR 2nd -1706
nct id: NCT03820622
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon
      dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with
      paclitaxel-eluting balloon (Bingo), and to provide the clinical data for the formal
      application in China and for the approvement of China marketing.
This is a prospective, multicenter, randomize, control and non-inferior study. 220 patients
      with bifurcation lesions will be randomized 1:1 to each group. after the main branch has been
      treated successfully, and if the side branch's stenosis is more than 70% and can be
      pre-dilated by POBA (plain old balloon angioplasty) successfully, then randomizing. the
      patients in the study group will be treated with paclitaxel-eluting coronary artery balloon
      dilatation catheter (DIOR), while those in the control group will be treated with
      paclitaxel-eluting balloon (Bingo). Clinical follow-up will be conducted at baseline,
      operation, hospital discharge, 1 month, 6 months, 9 months and 12 months after operation, and
      angiographic follow-up will be conducted at 9 months. The primary endpoint is late lumen loss
      (LLL) in the balloon dilatation coverage area of side branch of at 9 month after operation.
      The secondary endpoints include device success, clinical success, target lesion failure
      (TLF), target lesion revascularization (TLR), clinical composite endpoints and imaging
      endpoints. The information of adverse events, serious adverse events and device defects will
      be collected during the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: late lumen loss
time frame: 9 months after operation
description: in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)
measure: device success
time frame: immediately post procedure
description: define as dilation success in the side branch lesion by study balloon or control ballon, that is the residual stenosis ≤50%，TIMI (Thrombolysis In Myocardial Infarction) 3 flow and without type C or above dissection
measure: clinical success
time frame: 1 month after operation
description: define as absence of patients oriented composite endpoints (PoCE) during hospitalization, based on the device success.
measure: device oriented composite endpoints (DoCE)
time frame: 1, 6, 9, 12 month after operation
description: that is TLF, define as the composite endpoint include cardiac death, target vessel myocardial infarction and ischemic driven target lesion revascularization (ID-TLR)
measure: patients oriented composite endpoints (PoCE)
time frame: 1, 6, 9, 12 month after operation
description: define as a composite endpoints of all cause death, any myocardial infarction and any revascularization
measure: all cause death
time frame: 1, 6, 9, 12 month after operation
description: include cardiac death, vascular death, noncardiovascular death
measure: myocardial infarction (MI)
time frame: 1, 6, 9, 12 month after operation
description: target vessel MI, non-target vessel MI
measure: target lesion revasculation
time frame: 1, 6, 9, 12 month after operation
description: ischemic driven, non-ischemic driven
measure: target vessel revasculation
time frame: 1, 6, 9, 12 month after operation
description: ischemic driven, non-ischemic driven
measure: any coronary revasculation
time frame: 1, 6, 9, 12 month after operation
measure: thrombosis in the side branch lesion
time frame: 1, 6, 9, 12 month after operation
measure: angiographic endpoints-late loss of side branch
time frame: 9 months after operation
description: assess in millimeter
measure: angiographic endpoints-minimal lumen diameter (MLD) of side branch
time frame: 9 months after operation
description: assess in millimeter
measure: angiographic endpoints-diameter stenosis (DS)
time frame: 9 months after operation
description: assess in percentage
measure: angiographic endpoints-angiographic binary restenosis (ABR)
time frame: 9 months after operation
description: assess in percentage
arm group label: DIOR group
arm group type: Experimental
description: in this group, patients will be treated with Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
arm group label: Bingo group
arm group type: Active Comparator
description: in this group, patients will be treated with Paclitaxel-Eluting Balloon (Bingo)
intervention type: Device
intervention name: Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
description: patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
arm group label: DIOR group
intervention type: Device
intervention name: Paclitaxel-Eluting Balloon (Bingo)
description: patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)
arm group label: Bingo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yaling Han, professor
role: Principal Investigator
affiliation: The General Hospital of Northern Theater Command
last name: Bing Wang, professor
phone: 86-024-28851120
email: wangbindl@hotmail.com
last name: Geng Wang, professor
phone: 86-024-28851120
email: wanggeng69@163.com
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country: China
responsible party type: Sponsor
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
sharing ipd: Undecided