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/NCT06009146</url>
    </required_header>
    <id_info>
      <org_study_id>IPOD-Real Study</org_study_id>
      <nct_id>NCT06009146</nct_id>
    </id_info>
    <brief_title>Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.</brief_title>
    <official_title>Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xuanwu Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital of Chengdu University of Traditional Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Dalian Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Huashan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Pudong Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hebei General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>LanZhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Hospital University of South China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Affiliated Hospital of Qingdao University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Qingdao haici hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Tsinghua Changgeng Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Hospital of Tsinghua University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanxi Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Luhe Teaching Hospital of the Capital Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tianjin First Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tianjin Medical University General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Renmin Hospital of Wuhan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Xinjiang Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Zhengzhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiyuan Hospital of China Academy of Chinese Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiangya Hospital of Central South University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Xuanwu Hospital, Beijing</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>
        This study is a prospective, multi-center observational study, which evaluates the&#xD;
        effectiveness and safety of endovascular therapy in the real world for infrapopliteal&#xD;
        arterial occlusive disease from intermittent claudication to chronic threatening limb&#xD;
        ischemia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, multi-center observational study. This study will be conducted&#xD;
        at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the&#xD;
        effectiveness and safety of endovascular therapy in the real world for infrapopliteal&#xD;
        arterial occlusive disease from intermittent claudication to chronic threatening limb&#xD;
        ischemia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Freedom from major adverse event rate</measure>
      <time_frame>12 months</time_frame>
      <description>Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Amputation-free survival</measure>
      <time_frame>12 months</time_frame>
      <description>Freedom from death and major amputation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival</measure>
      <time_frame>12 months</time_frame>
      <description>Freedom from all-cause mortality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Freedom from major amputation</measure>
      <time_frame>12 months</time_frame>
      <description>Freedom from major amputation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Freedom from CDTLR</measure>
      <time_frame>12 months</time_frame>
      <description>Freedom from clinical driven target lesion revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Freedom from clinical driven target limb revascularization</measure>
      <time_frame>12 months</time_frame>
      <description>Freedom from clinical driven target limb revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rutherford categories</measure>
      <time_frame>12 months</time_frame>
      <description>Rutherford categories</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wound condition</measure>
      <time_frame>12 months</time_frame>
      <description>Wound and foot infections were scored using WIfI system.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complication rates</measure>
      <time_frame>1 week</time_frame>
      <description>Minor and Major complications rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life score</measure>
      <time_frame>12 months</time_frame>
      <description>Vascular quality of life questionnaire was used.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">3000</enrollment>
    <condition>Infrapopliteal Artery Occlusive Disease</condition>
    <condition>Endovascular Treatment</condition>
    <arm_group>
      <arm_group_label>Rutherford scale &lt; 4</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Rutherford scale 4-5</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Rutherford scale 6</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Endovascular treatment</intervention_name>
      <description>Endovascular treatment for infrapopliteal arterial disease.</description>
      <arm_group_label>Rutherford scale 4-5</arm_group_label>
      <arm_group_label>Rutherford scale 6</arm_group_label>
      <arm_group_label>Rutherford scale &lt; 4</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal&#xD;
          artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular&#xD;
          trunk) need to receive endovascular treatment, regardless of whether there is a combination&#xD;
          of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs,&#xD;
          contrast agents, etc., and those who are unable to undergo endovascular therapy for other&#xD;
          reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans；&#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>Lianrui Guo, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Xuanwu Hospital, Beijing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lianrui Guo, M.D.</last_name>
      <phone>+8613671009746</phone>
      <email>lianruiguo@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xixiang Gao, M.D.</last_name>
      <phone>+8613581674309</phone>
      <email>vascsurgeon@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Xuanwu Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100053</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xixiang Gao, M.D.</last_name>
        <phone>+8613581674309</phone>
        <email>vascsurgeon@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Endovascular Treatment</keyword>
    <keyword>Infrapopliteal Artery Disease</keyword>
    <keyword>Drug-coated Balloons</keyword>
    <keyword>Angioplasty</keyword>
    <keyword>Atherectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arterial Occlusive Diseases</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/NCT06009146
  org study id: IPOD-Real Study
  nct id: NCT06009146
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  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective, multi-center observational study, which evaluates the
        effectiveness and safety of endovascular therapy in the real world for infrapopliteal
        arterial occlusive disease from intermittent claudication to chronic threatening limb
        ischemia.
  This study is a prospective, multi-center observational study. This study will be conducted
        at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the
        effectiveness and safety of endovascular therapy in the real world for infrapopliteal
        arterial occlusive disease from intermittent claudication to chronic threatening limb
        ischemia.
  observational model: Cohort
  time perspective: Prospective
  measure: Freedom from major adverse event rate
  time frame: 12 months
  description: Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).
  measure: Amputation-free survival
  time frame: 12 months
  description: Freedom from death and major amputation
  measure: Survival
  time frame: 12 months
  description: Freedom from all-cause mortality.
  measure: Freedom from major amputation
  time frame: 12 months
  description: Freedom from major amputation
  measure: Freedom from CDTLR
  time frame: 12 months
  description: Freedom from clinical driven target lesion revascularization
  measure: Freedom from clinical driven target limb revascularization
  time frame: 12 months
  description: Freedom from clinical driven target limb revascularization
  measure: Rutherford categories
  time frame: 12 months
  description: Rutherford categories
  measure: Wound condition
  time frame: 12 months
  description: Wound and foot infections were scored using WIfI system.
  measure: Complication rates
  time frame: 1 week
  description: Minor and Major complications rates.
  measure: Quality of life score
  time frame: 12 months
  description: Vascular quality of life questionnaire was used.
  arm group label: Rutherford scale < 4
  arm group label: Rutherford scale 4-5
  arm group label: Rutherford scale 6
  intervention type: Device
  intervention name: Endovascular treatment
  description: Endovascular treatment for infrapopliteal arterial disease.
  arm group label: Rutherford scale 4-5
  arm group label: Rutherford scale 6
  arm group label: Rutherford scale < 4
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lianrui Guo, M.D.
  role: Study Chair
  affiliation: Xuanwu Hospital, Beijing
  last name: Lianrui Guo, M.D.
  phone: +8613671009746
  email: lianruiguo@sina.com
  last name: Xixiang Gao, M.D.
  phone: +8613581674309
  email: vascsurgeon@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Arterial Occlusive Diseases
  sharing ipd: Undecided