<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/NCT03780192</url>
  </required_header>
  <id_info>
    <org_study_id>SC-INS-001-2019</org_study_id>
    <nct_id>NCT03780192</nct_id>
  </id_info>
  <brief_title>INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique</brief_title>
  <acronym>insProvisional</acronym>
  <official_title>INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scitech Produtos Medicos Ltda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scitech Produtos Medicos Ltda</source>
  <oversight_info>
    <has_dmc>No</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>
      Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery&#xD;
      lesions, in order to preserve and not compromize the side branch using the provisional stent&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Anticipated">February 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Stenosis</measure>
    <time_frame>day 0</time_frame>
    <description>% of stenosis on side branch after stent placement on main vessel</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Bifurcation Lesion</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <description>Bifurcation lesion treatment using provisional stent technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inspiron Sirolimus Eluting Stent</intervention_name>
    <description>Bifurcation treatment using provisional stent technique</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with bifurcation coronary artery disease with indication for drug eluting&#xD;
        implantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with coronary artery disease on bifurcation anatomy with indication of drug&#xD;
             eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial&#xD;
             stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute Myocardial Infarction (STMI);&#xD;
&#xD;
          -  Chronic occlusion;&#xD;
&#xD;
          -  Cardiogenic shock;&#xD;
&#xD;
          -  Ejection fraction ≤ 20%;&#xD;
&#xD;
          -  Thrombocytopenia (≤ 50 mil);&#xD;
&#xD;
          -  DAPT contraindication;&#xD;
&#xD;
          -  Life expectancy of less than 12 months.&#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_contact>
    <last_name>Marco Wainstein, MD</last_name>
    <phone>+555133143537</phone>
    <email>marco.wainstein@hmv.org.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Moinhos de Vento</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Wainstein, MD</last_name>
      <email>marco.wainstein@hmv.org.br</email>
    </contact>
    <investigator>
      <last_name>Marco W Wainstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scitech Produtos Medicos Ltda</investigator_affiliation>
    <investigator_full_name>Marco Vugman Wainstein</investigator_full_name>
    <investigator_title>Principal Investigator Hospital Moinhos de Vento</investigator_title>
  </responsible_party>
  <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>Sirolimus</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/NCT03780192
org study id: SC-INS-001-2019
nct id: NCT03780192
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery
      lesions, in order to preserve and not compromize the side branch using the provisional stent
      technique.
observational model: Other
time perspective: Prospective
measure: Percentage of Stenosis
time frame: day 0
description: % of stenosis on side branch after stent placement on main vessel
arm group label: Treatment
description: Bifurcation lesion treatment using provisional stent technique
intervention type: Device
intervention name: Inspiron Sirolimus Eluting Stent
description: Bifurcation treatment using provisional stent technique
arm group label: Treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marco Wainstein, MD
phone: +555133143537
email: marco.wainstein@hmv.org.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Scitech Produtos Medicos Ltda
investigator full name: Marco Vugman Wainstein
investigator title: Principal Investigator Hospital Moinhos de Vento
mesh term: Coronary Artery Disease
mesh term: Sirolimus
sharing ipd: No