<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/NCT02972671</url>
  </required_header>
  <id_info>
    <org_study_id>MIS-JPN-2016-05</org_study_id>
    <nct_id>NCT02972671</nct_id>
  </id_info>
  <brief_title>Trial of MiStent Compared to Xience in Japan</brief_title>
  <acronym>DESSOLVEJ</acronym>
  <official_title>Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Micell Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardialysis BV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ClinLogix. LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Micell Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at&#xD;
      12 months in a non-inferiority trial in a &quot;real world&quot; patient population and to confirm that&#xD;
      the domestic extrapolation of the DESSOLVE III study results is valid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, 1:1 balanced, controlled, double-blind, multi-center study&#xD;
      comparing clinical outcomes at 12 months between MT005 (MiStent) and XIENCE in an all-comers&#xD;
      population, including patients with symptomatic coronary artery disease including patients&#xD;
      with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for&#xD;
      percutaneous coronary interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 28, 2016</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death</measure>
    <time_frame>12 Months</time_frame>
    <description>The proportion of patients in each arm that experience TLF will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization (TLR)</measure>
    <time_frame>12 Months</time_frame>
    <description>The proportion of patients in each arm that experience TLR will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Myocardial Infarction (TV-MI)</measure>
    <time_frame>12 Months</time_frame>
    <description>The proportion of patients in each arm that experience TV-MI will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>12 Months</time_frame>
    <description>The proportion of patients in each arm that experience Cardiac Death will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Coronary (Artery); Disease</condition>
  <arm_group>
    <arm_group_label>MiStent (MT005) Coronary Artery Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xience Coronary Artery Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MiStent (MT005) Coronary Artery Stent</intervention_name>
    <description>Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions</description>
    <arm_group_label>MiStent (MT005) Coronary Artery Stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Xience Coronary Artery Stent</intervention_name>
    <description>Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions</description>
    <arm_group_label>Xience Coronary Artery Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients ≥20 years;&#xD;
&#xD;
          -  Patients who are eligible for percutaneous coronary intervention (PCI);&#xD;
&#xD;
          -  The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm. All&#xD;
             lesions of the patient must comply with the angiographic inclusion criteria and no&#xD;
             more than 4 stents per patient are to be implanted.&#xD;
&#xD;
          -  The patient is judged to be capable of providing voluntary informed consent and has&#xD;
             been fully informed of the nature of the study, is willing to comply with all study&#xD;
             requirements and will provide written informed consent as approved by the Ethics&#xD;
             Committee of the respective clinical site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy or breastfeeding at time of randomization or planned pregnancy for 12&#xD;
             months after the index treatment. Women of childbearing potential must have a negative&#xD;
             pregnancy test within 7 days of randomization;&#xD;
&#xD;
          -  Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium,&#xD;
             or to medications such as aspirin, heparin, bivalirudin, and all of the following&#xD;
             three medications: clopidogrel bisulfate, ticlopidine, prasugrel;&#xD;
&#xD;
          -  Concurrent medical condition with a life expectancy of less than 12 months;&#xD;
&#xD;
          -  The patient is unwilling/not able to return for outpatient clinic at 1, 6 and 12&#xD;
             months follow-up;&#xD;
&#xD;
          -  Currently participating in another trial and not yet at its primary endpoint;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shigeru Saito, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shonan Kamakura General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Iwaki Municipal Iwaki Kyoritsu Hospital</name>
      <address>
        <city>Iwaki-shi</city>
        <state>Fukushima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Rosai Hospital</name>
      <address>
        <city>Amagasaki-shi</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tenyokai Central Hospital</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagoshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanto Rosai Hospital</name>
      <address>
        <city>Kawasaki-shi</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinkoga Hospital</name>
      <address>
        <city>Kurume-shi</city>
        <state>Kurume-shi, Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omihachiman Community Medical Center</name>
      <address>
        <city>Omihachiman-shi</city>
        <state>Shiga</state>
        <zip>523-0082</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho Univ.Ohashi Medical Center</name>
      <address>
        <city>Meguro-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Institute Hospital</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saiseikai Yokohama Tobu Hospital</name>
      <address>
        <city>Kanagawa</city>
        <state>Yokohama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MiStent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary 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/NCT02972671
org study id: MIS-JPN-2016-05
nct id: NCT02972671
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at
      12 months in a non-inferiority trial in a "real world" patient population and to confirm that
      the domestic extrapolation of the DESSOLVE III study results is valid.
This is a prospective, randomized, 1:1 balanced, controlled, double-blind, multi-center study
      comparing clinical outcomes at 12 months between MT005 (MiStent) and XIENCE in an all-comers
      population, including patients with symptomatic coronary artery disease including patients
      with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for
      percutaneous coronary interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death
time frame: 12 Months
description: The proportion of patients in each arm that experience TLF will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
measure: Target Lesion Revascularization (TLR)
time frame: 12 Months
description: The proportion of patients in each arm that experience TLR will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
measure: Target Vessel Myocardial Infarction (TV-MI)
time frame: 12 Months
description: The proportion of patients in each arm that experience TV-MI will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
measure: Cardiac Death
time frame: 12 Months
description: The proportion of patients in each arm that experience Cardiac Death will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure.
arm group label: MiStent (MT005) Coronary Artery Stent
arm group type: Experimental
description: A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted.
arm group label: Xience Coronary Artery Stent
arm group type: Active Comparator
description: Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted
intervention type: Device
intervention name: MiStent (MT005) Coronary Artery Stent
description: Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
arm group label: MiStent (MT005) Coronary Artery Stent
intervention type: Device
intervention name: Xience Coronary Artery Stent
description: Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
arm group label: Xience Coronary Artery Stent
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Shigeru Saito, MD
role: Principal Investigator
affiliation: Shonan Kamakura General Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Coronary Disease
sharing ipd: No