<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/NCT01725373</url>
  </required_header>
  <id_info>
    <org_study_id>LRB-06-012</org_study_id>
    <nct_id>NCT01725373</nct_id>
  </id_info>
  <brief_title>Angioplasty of Left Main - lAriboisiere Registry</brief_title>
  <acronym>ALMA</acronym>
  <official_title>Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Lariboisière</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Lariboisière</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with unprotected left main disease (ULMD), angioplasty is emerging as an&#xD;
      alternative technique. The investigators aimed to determine the rate of major cardiovascular&#xD;
      events in patients treated by angioplasty for ULMD in a &quot;real world&quot; registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current guidelines recommend coronary artery bypass graft surgery as the &quot;gold standard&quot;&#xD;
      treatment in patients with unprotected left main disease. However, patients with ULMD and&#xD;
      high surgical risk score or favourable anatomy are still referred for angioplasty. Recently,&#xD;
      several studies and registries comparing surgery and percutaneous intervention with drug&#xD;
      eluting stents report similar results regarding cardiovascular death and myocardial&#xD;
      infarction in patients with multivessel coronary artery disease including unprotected left&#xD;
      main disease.&#xD;
&#xD;
      The aim of the study is to evaluate major cardiovascular events in a &quot;real world&quot; registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Major cardiovascular events (MACCE)</measure>
    <time_frame>One year</time_frame>
    <description>Major cardiovascular events (MACCE)were measured after 1 year follow-up. MACCE included all-cause of death, stroke, myocardial infarction, and repeat revascularizations. Non-Q-wave myocardial infarction was defined using universal definition with troponin I. Stent thrombosis was defined according to the Academic Research Consortium definition as definite, probable, or possible and as early or late after the index procedure. Repeat revascularization was composed of any repeat percutaneous intervention or surgical bypass.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">125</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Angioplasty of left main</arm_group_label>
    <description>Patients with:&#xD;
stable or unstable angina and/or documented ischemia&#xD;
de novo ≥50% stenosis in the left main stem referred for angioplasty</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with stenosis of unprotected left main and schedulded angioplasty in&#xD;
        the Department of Cardiology, Lariboisiere Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable or unstable angina and/or documented ischemia&#xD;
&#xD;
          -  50% de novo ULMD referred for angioplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute coronary syndrome with ST elevation,&#xD;
&#xD;
          -  cardiogenic shock or out of hospital cardiac arrest&#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>Patrick Henry, MD-PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departement of Cardiology, Laribosiere Hospital, APHP</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>January 12, 2014</last_update_submitted>
  <last_update_submitted_qc>January 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hopital Lariboisière</investigator_affiliation>
    <investigator_full_name>Dr Jean-Guillaume DILLINGER</investigator_full_name>
    <investigator_title>Principal investigator - Medical Doctor in the Departement of Cardiology</investigator_title>
  </responsible_party>
  <keyword>left main, stent,angioplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01725373
org study id: LRB-06-012
nct id: NCT01725373
lead sponsor: 
has dmc: No
In patients with unprotected left main disease (ULMD), angioplasty is emerging as an
      alternative technique. The investigators aimed to determine the rate of major cardiovascular
      events in patients treated by angioplasty for ULMD in a "real world" registry.
Current guidelines recommend coronary artery bypass graft surgery as the "gold standard"
      treatment in patients with unprotected left main disease. However, patients with ULMD and
      high surgical risk score or favourable anatomy are still referred for angioplasty. Recently,
      several studies and registries comparing surgery and percutaneous intervention with drug
      eluting stents report similar results regarding cardiovascular death and myocardial
      infarction in patients with multivessel coronary artery disease including unprotected left
      main disease.

      The aim of the study is to evaluate major cardiovascular events in a "real world" registry.
observational model: Cohort
time perspective: Prospective
measure: Major cardiovascular events (MACCE)
time frame: One year
description: Major cardiovascular events (MACCE)were measured after 1 year follow-up. MACCE included all-cause of death, stroke, myocardial infarction, and repeat revascularizations. Non-Q-wave myocardial infarction was defined using universal definition with troponin I. Stent thrombosis was defined according to the Academic Research Consortium definition as definite, probable, or possible and as early or late after the index procedure. Repeat revascularization was composed of any repeat percutaneous intervention or surgical bypass.
arm group label: Angioplasty of left main
description: Patients with:
stable or unstable angina and/or documented ischemia
de novo ≥50% stenosis in the left main stem referred for angioplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Henry, MD-PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hopital Lariboisière
investigator full name: Dr Jean-Guillaume DILLINGER
investigator title: Principal investigator - Medical Doctor in the Departement of Cardiology
mesh term: Coronary Artery Disease