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/NCT05965271</url>
    </required_header>
    <id_info>
      <org_study_id>Fabulous WQ-F02</org_study_id>
      <nct_id>NCT05965271</nct_id>
    </id_info>
    <brief_title>A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection</brief_title>
    <official_title>A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hangzhou Endonom Medtech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hangzhou Endonom Medtech Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous&#xD;
        thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on&#xD;
        PETTICOAT technique.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Major adverse events</measure>
      <time_frame>within 30 days after operation</time_frame>
      <description>Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immediate technical success</measure>
      <time_frame>Immediate during operation</time_frame>
      <description>Immediate technical success was defined as the stent was successfully delivered to the intended site and released.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of diameter</measure>
      <time_frame>30 days, 3 months,6 months after operation</time_frame>
      <description>Changes of minimum diameter of true lumen, maximum diameter of false lumen and maximum total diameter of aorta before and after operation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major adverse events</measure>
      <time_frame>3 months,6 months after operation</time_frame>
      <description>Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause death and dissection related death</measure>
      <time_frame>3 months,6 months after operation</time_frame>
      <description>All-cause deaths are defined as death from any cause during the follow-up. Dissection related death refers to death caused by rupture of aortic dissection or endovascular treatment of aortic dissection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of reintervention</measure>
      <time_frame>30 days, 3 months,6 months after operation</time_frame>
      <description>Thoracotomy or secondary intervention due to aortic dissection</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">260</enrollment>
    <condition>Aortic Dissection</condition>
    <arm_group>
      <arm_group_label>Fabulous Thoracic Aortic Stent System</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fabulous Thoracic Aortic Stent System</intervention_name>
      <description>Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System</description>
      <arm_group_label>Fabulous Thoracic Aortic Stent System</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Stanford type B aortic dissection are treated with Fabulous Thoracic Aortic&#xD;
          Stent System in the real world.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years old, regardless of gender;&#xD;
  &#xD;
            -  Subject was diagnosed with Stanford Type B dissection and treated with Fabulous&#xD;
               thoracic aortic stent system, including either a covered stent system, a bare stent,&#xD;
               or both;&#xD;
  &#xD;
            -  With appropriate arterial access and suitable for endovascular aortic repair;&#xD;
  &#xD;
            -  Subjects could understand the purpose of the trial, volunteered to participate in the&#xD;
               study, signed the informed consent form by themselves or their legal representatives,&#xD;
               and were willing to complete the follow-up as required by the protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients have participated in clinical trials of other drugs or medical devices&#xD;
               related to target lesion treatment or have participated in clinical trials of other&#xD;
               drugs or medical devices and have not reached the primary endpoint;&#xD;
  &#xD;
            -  Patients were unable or unwilling to participate in the study;&#xD;
  &#xD;
            -  Patients were judged by the investigator to be ineligible for participation in the&#xD;
               trial.&#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_contact>
      <last_name>Weiguo Fu, Professor</last_name>
      <phone>13801760929</phone>
      <email>fu.weiguo@zs-hospital.sh.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital Of Harbin Medical University</name>
        <address>
          <city>Harbin</city>
          <state>Heilongjiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Baodong Xie</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wuhan Asia General Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhendong Hua</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Central Hospital of Dalian University of Technology</name>
        <address>
          <city>Dalian</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xijing Zhuang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital of Yunnan Province</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Kunmei Gong</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing Anzhen Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xi Guo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fu Weiguo</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Weiguo Fu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Chest Hospital</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dan Zhu</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Aortic Dissection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Dissection</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/NCT05965271
  org study id: Fabulous WQ-F02
  nct id: NCT05965271
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous
        thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.
  Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on
        PETTICOAT technique.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Major adverse events
  time frame: within 30 days after operation
  description: Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.
  measure: Immediate technical success
  time frame: Immediate during operation
  description: Immediate technical success was defined as the stent was successfully delivered to the intended site and released.
  measure: Change of diameter
  time frame: 30 days, 3 months,6 months after operation
  description: Changes of minimum diameter of true lumen, maximum diameter of false lumen and maximum total diameter of aorta before and after operation.
  measure: Major adverse events
  time frame: 3 months,6 months after operation
  description: Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia.
  measure: All-cause death and dissection related death
  time frame: 3 months,6 months after operation
  description: All-cause deaths are defined as death from any cause during the follow-up. Dissection related death refers to death caused by rupture of aortic dissection or endovascular treatment of aortic dissection.
  measure: The incidence of reintervention
  time frame: 30 days, 3 months,6 months after operation
  description: Thoracotomy or secondary intervention due to aortic dissection
  arm group label: Fabulous Thoracic Aortic Stent System
  intervention type: Device
  intervention name: Fabulous Thoracic Aortic Stent System
  description: Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System
  arm group label: Fabulous Thoracic Aortic Stent System
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Weiguo Fu, Professor
  phone: 13801760929
  email: fu.weiguo@zs-hospital.sh.cn
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
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  country: China
  responsible party type: Sponsor
  mesh term: Aortic Dissection