xml: <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/NCT05963620</url>
    </required_header>
    <id_info>
      <org_study_id>2021-0444</org_study_id>
      <nct_id>NCT05963620</nct_id>
    </id_info>
    <brief_title>Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery</brief_title>
    <official_title>Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Heart Center Leipzig - University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Heart Center Leipzig - University Hospital</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>
        This is a long-term follow-up of a completed clinical trial which compared percutaneous&#xD;
        coronary intervention (PCI) using sirolimus-eluting stents and coronary artery bypass&#xD;
        grafting (CABG) in patients with unprotected left main coronary artery disease.&#xD;
  &#xD;
        The purpose of the study is to obtain retrospective long-term data on clinical outcome of the&#xD;
        study population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The randomized multicenter, open-label trial &quot;Percutaneous Coronary Intervention (PCI) With&#xD;
        Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With&#xD;
        Significant Left Main Stenosis&quot; was conducted at 4 tertiary care centers in Germany. 201&#xD;
        patients with unprotected left main stem stenosis (≥50%) with or without additional&#xD;
        multivessel coronary artery disease were enrolled in a 1:1 ratio from July 2003 through&#xD;
        February 2009. Results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/&#xD;
  &#xD;
        Long-term follow-up will be performed by a structured telephone interview using a&#xD;
        standardized questionnaire by an interviewer blinded to treatment allocation. Wherever&#xD;
        possible, data will be completed and verified by health care records. Retrospective data of&#xD;
        the underlying randomized study will be included in data analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>All-cause death</measure>
      <time_frame>approximately 15 years after procedure</time_frame>
      <description>further categorized into cardiovascular, noncardiovascular, and undetermined deaths</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>composite secondary endpoint</measure>
      <time_frame>approximately 15 years after procedure</time_frame>
      <description>all-cause death, myocardial infarction or repeat target vessel revascularization</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">201</enrollment>
    <condition>Coronary Stenosis</condition>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>percutaneous coronary intervention (PCI)</arm_group_label>
      <description>percutaneous coronary intervention (PCI) with sirolimus-eluting stents</description>
    </arm_group>
    <arm_group>
      <arm_group_label>coronary artery bypass grafting (CABG)</arm_group_label>
      <description>coronary artery bypass graft surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>percutaneous coronary intervention vs bypass graft surgery</intervention_name>
      <description>retrieve long term follow up data on clinical outcome of study population, no intervention</description>
      <arm_group_label>coronary artery bypass grafting (CABG)</arm_group_label>
      <arm_group_label>percutaneous coronary intervention (PCI)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          participants of the preceding study: Percutaneous Coronary Intervention (PCI) With&#xD;
          Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With&#xD;
          Significant Left Main Stenosis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  alive participants of underlying study who give their consent to participate&#xD;
  &#xD;
            -  deceased participants of underlying study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  alive participants of underlying study who do not consent&#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>Steffen Desch, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Heart Center Leipzig at University of Leipzig</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Universitäts-Herzzentrum Freiburg Bad Krozingen</name>
        <address>
          <city>Bad Krozingen</city>
          <state>Baden Würtemberg</state>
          <zip>79189</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Klinikum der Ludwig-Maximilians Universität München</name>
        <address>
          <city>München</city>
          <state>Bayern</state>
          <zip>80336</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>München Klinik Neuperlach</name>
        <address>
          <city>München</city>
          <state>Bayern</state>
          <zip>81737</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Heart Center Leipzig at University of Leipzig</name>
        <address>
          <city>Leipzig</city>
          <state>Saxony</state>
          <zip>04289</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Percutaneous coronary intervention</keyword>
    <keyword>sirolimus-eluting stent</keyword>
    <keyword>coronary artery bypass grafting</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Coronary Stenosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963620
  org study id: 2021-0444
  nct id: NCT05963620
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a long-term follow-up of a completed clinical trial which compared percutaneous
        coronary intervention (PCI) using sirolimus-eluting stents and coronary artery bypass
        grafting (CABG) in patients with unprotected left main coronary artery disease.
  
        The purpose of the study is to obtain retrospective long-term data on clinical outcome of the
        study population.
  The randomized multicenter, open-label trial "Percutaneous Coronary Intervention (PCI) With
        Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With
        Significant Left Main Stenosis" was conducted at 4 tertiary care centers in Germany. 201
        patients with unprotected left main stem stenosis (≥50%) with or without additional
        multivessel coronary artery disease were enrolled in a 1:1 ratio from July 2003 through
        February 2009. Results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/
  
        Long-term follow-up will be performed by a structured telephone interview using a
        standardized questionnaire by an interviewer blinded to treatment allocation. Wherever
        possible, data will be completed and verified by health care records. Retrospective data of
        the underlying randomized study will be included in data analysis.
  observational model: Cohort
  time perspective: Prospective
  measure: All-cause death
  time frame: approximately 15 years after procedure
  description: further categorized into cardiovascular, noncardiovascular, and undetermined deaths
  measure: composite secondary endpoint
  time frame: approximately 15 years after procedure
  description: all-cause death, myocardial infarction or repeat target vessel revascularization
  arm group label: percutaneous coronary intervention (PCI)
  description: percutaneous coronary intervention (PCI) with sirolimus-eluting stents
  arm group label: coronary artery bypass grafting (CABG)
  description: coronary artery bypass graft surgery
  intervention type: Other
  intervention name: percutaneous coronary intervention vs bypass graft surgery
  description: retrieve long term follow up data on clinical outcome of study population, no intervention
  arm group label: coronary artery bypass grafting (CABG)
  arm group label: percutaneous coronary intervention (PCI)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Steffen Desch, MD
  role: Study Chair
  affiliation: Heart Center Leipzig at University of Leipzig
  facility: 
  facility: 
  facility: 
  facility: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Coronary Stenosis