<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/NCT04471883</url>
  </required_header>
  <id_info>
    <org_study_id>00543186</org_study_id>
    <nct_id>NCT04471883</nct_id>
  </id_info>
  <brief_title>LATAM Bif Registry</brief_title>
  <official_title>Latin American Registry of Percutaneous Interventions in Coronary Bifurcations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LATAM Bifurcation Club</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LATAM Bifurcation Club</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The LATAM Bif Registy is an international and prospective registry of percutaneous coronary&#xD;
      interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to&#xD;
      investigate the current state and long-term outcomes of PCI in this complex subset of&#xD;
      coronary lesions in Latin America.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 15, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2030</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Target Lesion Revascularization</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Coronary Bifurcation Lesion</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous coronary interventions</intervention_name>
    <description>Percutaneous coronary interventions in coronary bifurcation lesions</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients ≥18 years of age, who have at least one significant lesion in a coronary&#xD;
        bifurcation on diagnostic cinecoronary angiography and who are candidates to treatment with&#xD;
        PCI, regardless of the dedicated-technique used. Those patients who present lesions&#xD;
        involving vessels &lt;2 mm by visual estimation and those who refuse to be included in the&#xD;
        registry will be excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Any type of bifurcation lesion&#xD;
&#xD;
          -  Side-branch reference diameter &gt;= 2 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Protected left main disease in patients with previous CABG&#xD;
&#xD;
          -  Patients who refuse to be included in the registry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Marcelo A. Abud, M.D</last_name>
    <phone>54 11 33085742</phone>
    <email>latambif@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucio T. Padilla, M.D</last_name>
    <email>latambif@gmail.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD planned</ipd_description>
  </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/NCT04471883
org study id: 00543186
nct id: NCT04471883
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The LATAM Bif Registy is an international and prospective registry of percutaneous coronary
      interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to
      investigate the current state and long-term outcomes of PCI in this complex subset of
      coronary lesions in Latin America.
observational model: Cohort
time perspective: Prospective
measure: Cardiac Death
time frame: 5 years
measure: Myocardial Infarction
time frame: 5 years
measure: Target Lesion Revascularization
time frame: 5 years
measure: Stent thrombosis
time frame: 5 years
measure: Major bleeding
time frame: 5 years
intervention type: Procedure
intervention name: Percutaneous coronary interventions
description: Percutaneous coronary interventions in coronary bifurcation lesions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Marcelo A. Abud, M.D
phone: 54 11 33085742
email: latambif@gmail.com
last name: Lucio T. Padilla, M.D
email: latambif@gmail.com
responsible party type: Sponsor
sharing ipd: No
ipd description: No IPD planned