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/NCT06022653</url>
    </required_header>
    <id_info>
      <org_study_id>2023-1234</org_study_id>
      <nct_id>NCT06022653</nct_id>
    </id_info>
    <brief_title>Asan Aorta and Peripheral Registry</brief_title>
    <acronym>PTA</acronym>
    <official_title>Evaluation of Patients Underwent Revascularization of Aorta or Peripheral Artery at the Peripheral Vascular Disease Center, Asan Medical Center; A Single Center, Retrospective/Prospective Observational Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Asan Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Asan Medical Center</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 purpose of this study is to evaluate the clinical results of patients who received&#xD;
        revascularization of the aorta and peripheral artery at Asan Medical Center.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a single center retrospective and prospective observational study to evaluate&#xD;
        the clinical results of patients who received revascularization of the aorta and peripheral&#xD;
        artery at asan medical center.&#xD;
  &#xD;
        Data will be collected on approximately 6,000 subjects in asan medical center. Individuals&#xD;
        will be followed up at 1, 6, and 12 months, 3, 5years up to 10 years by telephone call or&#xD;
        hospital visit.&#xD;
  &#xD;
        Data collected during all follow-up visits will include a composite of major adverse limb&#xD;
        events, or death from any cause.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2044</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2034</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of death from any cause</measure>
      <time_frame>10years</time_frame>
      <description>all-cause death</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of major Adverse Limb Events</measure>
      <time_frame>10years</time_frame>
      <description>above-ankle amputation of the index limb,major index-limb reintervention including new bypass,interposition graft revision,thrombectomy, or thrombolysis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of death from all cause including cardiovascular death</measure>
      <time_frame>10years</time_frame>
      <description>cardiovascular death,Non-cardiovascular death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of stroke</measure>
      <time_frame>10years</time_frame>
      <description>Ischemic , hemorrhagic , mixed Stroke</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of myocardial Infarction</measure>
      <time_frame>10years</time_frame>
      <description>Spontaneous MI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of vascular complication</measure>
      <time_frame>10years</time_frame>
      <description>Vascular complication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of bleeding</measure>
      <time_frame>10years</time_frame>
      <description>TIMI bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Success of the procedure</measure>
      <time_frame>10years</time_frame>
      <description>PTA (target artery path) TEVAR and EVAR if aneurysm is diagnosed (the endograft is deployed accurately and the aneurysm is excluded from the circulation), if dissection is diagnosed(closure of the primary entry tear (i.e. absence of type Ia endoleak) and induction of false lumen thrombosis)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of limb amputation</measure>
      <time_frame>10years</time_frame>
      <description>Additional limb amputation of the index limb,Additional limb amputation of the non-index limb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of reintervention of aorta , reintervention of index limb or non-index limb</measure>
      <time_frame>10years</time_frame>
      <description>Reintervention of aorta , reintervention of index limb or non-index limb</description>
    </secondary_outcome>
    <enrollment type="Anticipated">6000</enrollment>
    <condition>Aorta Disease</condition>
    <condition>Peripheral Artery Disease</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Treatment</intervention_name>
      <description>EVAR,TEVAR,PTA</description>
      <other_name>Intervention</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients underwent Revascularization of Aorta or Peripheral artery from 2011 at the&#xD;
          Peripheral Vascular Disease Center, Asan Medical Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients underwent Revascularization of Aorta or Peripheral artery from 2011 at the&#xD;
               Peripheral Vascular Disease Center, Asan Medical Center&#xD;
  &#xD;
            -  Patients with aortic and peripheral artery disease are defined as:&#xD;
  &#xD;
          Thoacic aorta disease/ abdominal aorta disease&#xD;
  &#xD;
            1. Aneurysm&#xD;
  &#xD;
            2. Aortic dissection&#xD;
  &#xD;
            3. Penetrating aortic ulcer&#xD;
  &#xD;
          Peripheral artery occlusive disease&#xD;
  &#xD;
            1. Chronic Limb-Threatening Ischemia&#xD;
  &#xD;
            2. Claudication&#xD;
  &#xD;
            3. Acute limb ischemia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For prospective cohort, not agreeing to participate with written informed consent form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Seung-Whan Lee</last_name>
      <role>Principal Investigator</role>
      <affiliation>Asan Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jung hwa Lee, RN</last_name>
      <phone>82-2045-3398</phone>
      <email>nurse9726@amc.seoul.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Seung-Whan Lee</last_name>
      <phone>82 2-3010-3170</phone>
      <email>seungwlee@amc.seoul.kr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Asan Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Asan Medical Center</investigator_affiliation>
      <investigator_full_name>Seung-Whan Lee, M.D., Ph.D.</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Revascularization of Aorta or Peripheral artery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06022653
  org study id: 2023-1234
  nct id: NCT06022653
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the clinical results of patients who received
        revascularization of the aorta and peripheral artery at Asan Medical Center.
  This study is a single center retrospective and prospective observational study to evaluate
        the clinical results of patients who received revascularization of the aorta and peripheral
        artery at asan medical center.
  
        Data will be collected on approximately 6,000 subjects in asan medical center. Individuals
        will be followed up at 1, 6, and 12 months, 3, 5years up to 10 years by telephone call or
        hospital visit.
  
        Data collected during all follow-up visits will include a composite of major adverse limb
        events, or death from any cause.
  observational model: Cohort
  time perspective: Other
  measure: Rate of death from any cause
  time frame: 10years
  description: all-cause death
  measure: Rate of major Adverse Limb Events
  time frame: 10years
  description: above-ankle amputation of the index limb,major index-limb reintervention including new bypass,interposition graft revision,thrombectomy, or thrombolysis
  measure: Rate of death from all cause including cardiovascular death
  time frame: 10years
  description: cardiovascular death,Non-cardiovascular death
  measure: Rate of stroke
  time frame: 10years
  description: Ischemic , hemorrhagic , mixed Stroke
  measure: Rate of myocardial Infarction
  time frame: 10years
  description: Spontaneous MI
  measure: Rate of vascular complication
  time frame: 10years
  description: Vascular complication
  measure: Rate of bleeding
  time frame: 10years
  description: TIMI bleeding
  measure: Success of the procedure
  time frame: 10years
  description: PTA (target artery path) TEVAR and EVAR if aneurysm is diagnosed (the endograft is deployed accurately and the aneurysm is excluded from the circulation), if dissection is diagnosed(closure of the primary entry tear (i.e. absence of type Ia endoleak) and induction of false lumen thrombosis)
  measure: Rate of limb amputation
  time frame: 10years
  description: Additional limb amputation of the index limb,Additional limb amputation of the non-index limb
  measure: Rate of reintervention of aorta , reintervention of index limb or non-index limb
  time frame: 10years
  description: Reintervention of aorta , reintervention of index limb or non-index limb
  intervention type: Other
  intervention name: Treatment
  description: EVAR,TEVAR,PTA
  other name: Intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Seung-Whan Lee
  role: Principal Investigator
  affiliation: Asan Medical Center
  last name: Jung hwa Lee, RN
  phone: 82-2045-3398
  email: nurse9726@amc.seoul.kr
  last name: Seung-Whan Lee
  phone: 82 2-3010-3170
  email: seungwlee@amc.seoul.kr
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Asan Medical Center
  investigator full name: Seung-Whan Lee, M.D., Ph.D.
  investigator title: Principal investigator
  mesh term: Peripheral Arterial Disease
  sharing ipd: Undecided