<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/NCT04405063</url>
  </required_header>
  <id_info>
    <org_study_id>CEP-DS1001</org_study_id>
    <nct_id>NCT04405063</nct_id>
  </id_info>
  <brief_title>Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis</brief_title>
  <official_title>A Prospective, Multicenter, Sponsor Initiated, Randomized Controlled Trials to Evaluate the Safety and Efficacy of Genoss® DCB Compared to Sequent® Please in Korean Patients With Coronary Artery In-stent Restenosis (ISR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genoss Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genoss 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>
      The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon&#xD;
      (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months&#xD;
      after the procedure in patients with in-stent restenosis (ISR) compared with a product of the&#xD;
      same category (Sequent® Please)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized controlled trials to compare with the same-category medical device (Sequent®&#xD;
      Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7&#xD;
      institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was&#xD;
      assigned to the test group and the control group, and each of the test or control devices was&#xD;
      assigned to receive the procedure.&#xD;
&#xD;
      Drug release &quot;stents&quot; for PCI usually follow 9 months or 12 months, but the medical device&#xD;
      for this clinical trial has a drug coated &quot;balloon catheter&quot; and the mechanism of action is&#xD;
      different from the stent and the duration of follow up was set to 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">February 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In-segment late lumen loss after percutaneous coronary intervention in patients with ISR</measure>
    <time_frame>Follow-up angiography at 6 months after procedure</time_frame>
    <description>In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Genoss® DCB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel Coated PTCA Balloon Catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SeQuent® Please</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paclitaxel Coated PTCA Balloon Catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paclitaxel Coated PTCA Balloon Catheter</intervention_name>
    <description>Drug coated balloon</description>
    <arm_group_label>Genoss® DCB</arm_group_label>
    <arm_group_label>SeQuent® Please</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥19 years old&#xD;
&#xD;
          -  Patients with significant coronary artery stenosis including left main coronary lesion&#xD;
             (&gt; 50% diameter stenosis on coronary angiography)&#xD;
&#xD;
          -  Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic&#xD;
             myocardial ischemia&#xD;
&#xD;
          -  Patients suitable to receive coronary revascularization of any type&#xD;
&#xD;
          -  Restenosis Mehran type I-III after stent implantation for the first time&#xD;
&#xD;
          -  Patients with In-stent restenosis after 90 days of the stent implantation, and the&#xD;
             degree of restenosis corresponds to Mehran type I-Ⅲ.&#xD;
&#xD;
          -  Diameter of the stent with restenosis should be 2.0-4.0mm (included). Length of the&#xD;
             stenosis lesion should be no more than 40mm&#xD;
&#xD;
          -  In case of voluntarily deciding to participate in this clinical trial by signing the&#xD;
             informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Infarct related artery (IRA) lesions among patients with acute&#xD;
             myocardial infarction&#xD;
&#xD;
          -  Patients have restenosis lesions with thrombosis&#xD;
&#xD;
          -  Patients with a history of cardiogenic shock&#xD;
&#xD;
          -  Patients with total occlusion indicating TIMI 0 blood flow at the target lesion&#xD;
             (Mehran type IV stenosis)&#xD;
&#xD;
          -  Patients with graft vessel lesion&#xD;
&#xD;
          -  Patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and&#xD;
             paclitaxel&#xD;
&#xD;
          -  Patients with renal insufficiency (eGFR&lt;30mL/min)&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  The patients have a life expectancy of less than 12 months&#xD;
&#xD;
          -  Patients who had reduced immunity or clinically significant abnormalities in the&#xD;
             laboratory tests (hematological, serum biochemical, and urine tests) performed at the&#xD;
             time of screening&#xD;
&#xD;
          -  Patients who had clinically significant disorders in cardiovascular system, digestive&#xD;
             system, respiratory system, endocrine system, and central nervous system, or mental&#xD;
             illness that significantly affects this study&#xD;
&#xD;
          -  Patients who are unsuitable for the study according to the investigator judges&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>October 13, 2021</last_update_submitted>
  <last_update_submitted_qc>October 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>In-Stent Restenosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>


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/NCT04405063
org study id: CEP-DS1001
nct id: NCT04405063
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon
      (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months
      after the procedure in patients with in-stent restenosis (ISR) compared with a product of the
      same category (Sequent® Please)
In a randomized controlled trials to compare with the same-category medical device (Sequent®
      Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7
      institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was
      assigned to the test group and the control group, and each of the test or control devices was
      assigned to receive the procedure.

      Drug release "stents" for PCI usually follow 9 months or 12 months, but the medical device
      for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is
      different from the stent and the duration of follow up was set to 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: In-segment late lumen loss after percutaneous coronary intervention in patients with ISR
time frame: Follow-up angiography at 6 months after procedure
description: In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR
arm group label: Genoss® DCB
arm group type: Experimental
description: Paclitaxel Coated PTCA Balloon Catheter
arm group label: SeQuent® Please
arm group type: Active Comparator
description: Paclitaxel Coated PTCA Balloon Catheter
intervention type: Device
intervention name: Paclitaxel Coated PTCA Balloon Catheter
description: Drug coated balloon
arm group label: Genoss® DCB
arm group label: SeQuent® Please
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Paclitaxel
sharing ipd: No