<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/NCT03301246</url>
  </required_header>
  <id_info>
    <org_study_id>BROS-CLIN-2017-01</org_study_id>
    <nct_id>NCT03301246</nct_id>
  </id_info>
  <brief_title>Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease</brief_title>
  <official_title>Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eminence Clinical Research, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BrosMed Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eminence Clinical Research, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, non-randomized, open label, multi-center study including 60 patients&#xD;
      with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions&#xD;
      enrolled and treated in this investigational device study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who require initial pre-dilatation using the study device, and then undergo&#xD;
      definitive therapy using additional PTCA catheters and stents, according to standard of care&#xD;
      will be enrolled in this study.&#xD;
&#xD;
      A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated&#xD;
      using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm&#xD;
      dilatation catheters for pre-dilatation and will complete the study within the U.S. This&#xD;
      equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with&#xD;
      the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2018</start_date>
  <completion_date type="Actual">May 8, 2020</completion_date>
  <primary_completion_date type="Actual">January 29, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>45 patients will be treated using the 1.0mm dilatation catheter and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated. Patients may be consented, enrolled and treated until the sample size is reached, with n=60 completing the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure Success</measure>
    <time_frame>Day 1 - Index Procedure</time_frame>
    <description>Delivery of the catheter to and across lesion; inflation and deflation of the catheter; no vessel perforation, dissection or reduction in TIMI flow; and achievement of final TIMI flow grade 3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anticipated Adverse Events</measure>
    <time_frame>Day 1 - Index Procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Heart Disease, Ischemic</condition>
  <condition>Coronary Stenosis</condition>
  <arm_group>
    <arm_group_label>Artimes Pro Low Profile Dilatation Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Artimes Pro Low Profile Dilatation Catheter</intervention_name>
    <description>Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.</description>
    <arm_group_label>Artimes Pro Low Profile Dilatation Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age;&#xD;
&#xD;
          -  Willing and able to provide informed consent;&#xD;
&#xD;
          -  Willing and able to meet all study requirements;&#xD;
&#xD;
          -  Patients with symptomatic ischemic heart disease due to stenotic lesions or occlusions&#xD;
             in coronary arteries that are amenable to percutaneous coronary interventions;&#xD;
&#xD;
          -  Patients who tolerate DAPT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin,&#xD;
             anti-platelet medications, or sensitivity to contrast media, which cannot be&#xD;
             adequately pre-medicated;&#xD;
&#xD;
          -  LVEF &lt; 30%;&#xD;
&#xD;
          -  Evidence of an acute myocardial infarction within 72 hours of the intended index&#xD;
             procedure;&#xD;
&#xD;
          -  Planned treatment of unprotected left main disease;&#xD;
&#xD;
          -  History of cerebral vascular accident (CVA) within 6 months prior to consideration for&#xD;
             this study;&#xD;
&#xD;
          -  Transient ischemic attack (TIA) within 6 months prior to consideration for this study;&#xD;
&#xD;
          -  Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months prior to&#xD;
             consideration for this study;&#xD;
&#xD;
          -  History of bleeding diathesis or coagulopathy;&#xD;
&#xD;
          -  Refuses blood transfusions;&#xD;
&#xD;
          -  Any general contraindication to revascularization procedures;&#xD;
&#xD;
          -  Pregnant or lactating;&#xD;
&#xD;
          -  In the judgement of the investigator, patient is not a suitable candidate for this&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jasvinder Singh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Vincent Heart Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</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>Heart Diseases</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
    <mesh_term>Dilatation, Pathologic</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/NCT03301246
org study id: BROS-CLIN-2017-01
nct id: NCT03301246
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is a prospective, non-randomized, open label, multi-center study including 60 patients
      with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions
      enrolled and treated in this investigational device study.
Patients who require initial pre-dilatation using the study device, and then undergo
      definitive therapy using additional PTCA catheters and stents, according to standard of care
      will be enrolled in this study.

      A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated
      using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm
      dilatation catheters for pre-dilatation and will complete the study within the U.S. This
      equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with
      the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 45 patients will be treated using the 1.0mm dilatation catheter and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated. Patients may be consented, enrolled and treated until the sample size is reached, with n=60 completing the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Procedure Success
time frame: Day 1 - Index Procedure
description: Delivery of the catheter to and across lesion; inflation and deflation of the catheter; no vessel perforation, dissection or reduction in TIMI flow; and achievement of final TIMI flow grade 3.
measure: Anticipated Adverse Events
time frame: Day 1 - Index Procedure
arm group label: Artimes Pro Low Profile Dilatation Catheter
arm group type: Experimental
description: Subjects who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study.
intervention type: Device
intervention name: Artimes Pro Low Profile Dilatation Catheter
description: Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.
arm group label: Artimes Pro Low Profile Dilatation Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jasvinder Singh, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Heart Diseases
mesh term: Coronary Stenosis
mesh term: Ischemia
mesh term: Constriction, Pathologic
mesh term: Dilatation, Pathologic
sharing ipd: No