<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/NCT03263260</url>
  </required_header>
  <id_info>
    <org_study_id>Inspiron RL II</org_study_id>
    <nct_id>NCT03263260</nct_id>
  </id_info>
  <brief_title>Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent</brief_title>
  <acronym>Inspiron RL II</acronym>
  <official_title>Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and&#xD;
      efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of &quot;real-world&quot;&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0&#xD;
      mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.&#xD;
&#xD;
      Stent implantation should be performed according to the Instructions for Use and according to&#xD;
      the local practice. It is recommended that ECG and cardiac enzymes are collected before and&#xD;
      after procedure. Dual anti-platelet therapy is recommended for at least 6 months after&#xD;
      procedure.&#xD;
&#xD;
      Patients will be followed at 30 days, 1 and 2 years after procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 2, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 15, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Major Adverse Cardiac Events Rate</measure>
    <time_frame>12 months</time_frame>
    <description>Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Vessel and Lesion Revascularization Rates</measure>
    <time_frame>24 months</time_frame>
    <description>Target Vessel and Lesion Revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis Rate</measure>
    <time_frame>24 months</time_frame>
    <description>Stent Thrombosis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>implanted patients</arm_group_label>
    <description>Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>implant</intervention_name>
    <description>coronary stent implantation</description>
    <arm_group_label>implanted patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent&#xD;
        in native coronary arteries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older&#xD;
             and 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Safein Vein or Left Internal Mammary artery Grafts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90.619-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stent, DES, Inspiron</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery 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/NCT03263260
org study id: Inspiron RL II
nct id: NCT03263260
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and
      efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world"
      patients.
Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0
      mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.

      Stent implantation should be performed according to the Instructions for Use and according to
      the local practice. It is recommended that ECG and cardiac enzymes are collected before and
      after procedure. Dual anti-platelet therapy is recommended for at least 6 months after
      procedure.

      Patients will be followed at 30 days, 1 and 2 years after procedure.
observational model: Other
time perspective: Prospective
measure: Major Adverse Cardiac Events Rate
time frame: 12 months
description: Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis
measure: Target Vessel and Lesion Revascularization Rates
time frame: 24 months
description: Target Vessel and Lesion Revascularization
measure: Stent Thrombosis Rate
time frame: 24 months
description: Stent Thrombosis
arm group label: implanted patients
description: Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent
intervention type: Device
intervention name: implant
description: coronary stent implantation
arm group label: implanted patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No