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/NCT05965453</url>
    </required_header>
    <id_info>
      <org_study_id>No.XJTU1AF2023LSK-148</org_study_id>
      <nct_id>NCT05965453</nct_id>
    </id_info>
    <brief_title>Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome</brief_title>
    <acronym>ECAAS</acronym>
    <official_title>Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hanzhong Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Affiliated Hospital of Gansu Medical College</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Affiliated Hospital of Shaanxi University of Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xianyang Hospital of Yan'an University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Baoji Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>General Hospital of Ningxia Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>People's Hospital of Ningxia Hui Autonomous Region</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Qinghai Red Cross Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hanzhong People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>First Affiliated Hospital Xi'an Jiaotong University</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>
        The objective of this study to evaluate the safety and effectiveness of the Castor single&#xD;
        branch stent graft for endovascular repair of acute aortic syndrome patients without an&#xD;
        inadequate proximal landing zone (&lt;15mm)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this observational, ambispective, and multicenter cohort study is to evaluate&#xD;
        efficacy and safety of the Castor single branch stent graft.&#xD;
  &#xD;
        205 patients who received thoracic endovascular aortic repair by meant of the Castor single&#xD;
        branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled&#xD;
        patients have an inadequate proximal landing zone (&lt;15mm) , and they underwent routine&#xD;
        follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the&#xD;
        following, but not limited to assessment: physical examination, laboratory test and the CT&#xD;
        angiography.&#xD;
  &#xD;
        Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and&#xD;
        annually to 10-years post-procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2018</start_date>
    <completion_date type="Anticipated">June 1, 2032</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2032</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>Immediate post-operative technique success</measure>
      <time_frame>immediately post operation</time_frame>
      <description>Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined position, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure, and patent branch stents.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>All-cause mortality and major</measure>
      <time_frame>1-year post operation</time_frame>
      <description>All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography</measure>
      <time_frame>1-month, 6-months, 1-year, and annually to 10-years post operation</time_frame>
      <description>Major device or procedure related major adverse events as assessed by computer tomography angiography included: death, dissection or aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), retrograde type A aortic dissection, endoleaks, new disabling stroke, paraplegia, new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, lower limb ischemia (increase in Rutherford classification), access vessel thrombosis or rupture, conversion to open surgery, and stent migration, fracture or migration, stent graft infection, stent graft-induced new entry tear.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Aortic remodeling results as assessed by computer tomography angiography (the size of the true and false lumen of aorta, and the thrombosis degree of the false lumen of aorta)</measure>
      <time_frame>1-month, 6-months, 1-year, and annually to 10-years post operation</time_frame>
      <description>Compare the results of computer tomography angiography before operation and on the first-, 6th- and 12th-month post operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the stent graft to determine whether the blood vessel is successfully remodeled</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-intervention during follow-up</measure>
      <time_frame>1-month, 6-months, 1-year, and annually to 10-years post operation</time_frame>
      <description>Re-intervention result from device/procedure-related adverse events.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">205</enrollment>
    <condition>Acute Aortic Syndrome</condition>
    <arm_group>
      <arm_group_label>Participants received thoracic endovascular aortic repair with Castor single branch stent graft</arm_group_label>
      <description>Participants who have an inadequate proximal landing zone received thoracic endovascular aortic repair by meant of the Castor single branch stent graft</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>the Castor single branch stent graft</intervention_name>
      <description>Participants who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study.</description>
      <arm_group_label>Participants received thoracic endovascular aortic repair with Castor single branch stent graft</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients with acute Stanford type B aortic syndrome who received thoracic endovascular&#xD;
          aortic repair by meant of Castor single branch stent graft in the above 10 medical centers&#xD;
          from June 2018 to June 2022 were enrolled.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with acute Stanford type B aortic syndrome who received thoracic endovascular&#xD;
               aortic repair by meant of Castor single branch stent graft from June 2018 to June 2022&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with acute type B aortic syndrome with an adequate proximal landing zone&#xD;
               (≥15mm)&#xD;
  &#xD;
            -  Previous endovascular repair of the aorta&#xD;
  &#xD;
            -  Patients with missing data and loss of follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hongyan Tian, MD</last_name>
      <role>Study Chair</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hongyan Tian, MD</last_name>
      <phone>0086-13891981101</phone>
      <email>tianhongyan2020@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mengyang Kang, MD</last_name>
      <phone>0086-18717366324</phone>
      <email>kmy9610@stu.xjtu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>First Affiliated Hospital of Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongyan Tian</last_name>
        <phone>0086-13891981101</phone>
        <email>tianhongyan2020@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 27, 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>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Aortic Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05965453
  org study id: No.XJTU1AF2023LSK-148
  nct id: NCT05965453
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study to evaluate the safety and effectiveness of the Castor single
        branch stent graft for endovascular repair of acute aortic syndrome patients without an
        inadequate proximal landing zone (<15mm)
  The goal of this observational, ambispective, and multicenter cohort study is to evaluate
        efficacy and safety of the Castor single branch stent graft.
  
        205 patients who received thoracic endovascular aortic repair by meant of the Castor single
        branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled
        patients have an inadequate proximal landing zone (<15mm) , and they underwent routine
        follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the
        following, but not limited to assessment: physical examination, laboratory test and the CT
        angiography.
  
        Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and
        annually to 10-years post-procedure.
  observational model: Cohort
  time perspective: Other
  measure: Immediate post-operative technique success
  time frame: immediately post operation
  description: Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined position, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure, and patent branch stents.
  measure: All-cause mortality and major
  time frame: 1-year post operation
  description: All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.
  measure: Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography
  time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation
  description: Major device or procedure related major adverse events as assessed by computer tomography angiography included: death, dissection or aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), retrograde type A aortic dissection, endoleaks, new disabling stroke, paraplegia, new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, lower limb ischemia (increase in Rutherford classification), access vessel thrombosis or rupture, conversion to open surgery, and stent migration, fracture or migration, stent graft infection, stent graft-induced new entry tear.
  measure: Aortic remodeling results as assessed by computer tomography angiography (the size of the true and false lumen of aorta, and the thrombosis degree of the false lumen of aorta)
  time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation
  description: Compare the results of computer tomography angiography before operation and on the first-, 6th- and 12th-month post operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the stent graft to determine whether the blood vessel is successfully remodeled
  measure: Re-intervention during follow-up
  time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation
  description: Re-intervention result from device/procedure-related adverse events.
  arm group label: Participants received thoracic endovascular aortic repair with Castor single branch stent graft
  description: Participants who have an inadequate proximal landing zone received thoracic endovascular aortic repair by meant of the Castor single branch stent graft
  intervention type: Device
  intervention name: the Castor single branch stent graft
  description: Participants who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study.
  arm group label: Participants received thoracic endovascular aortic repair with Castor single branch stent graft
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: Hongyan Tian, MD
  role: Study Chair
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Hongyan Tian, MD
  phone: 0086-13891981101
  email: tianhongyan2020@163.com
  last name: Mengyang Kang, MD
  phone: 0086-18717366324
  email: kmy9610@stu.xjtu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Acute Aortic Syndrome
  mesh term: Syndrome
  sharing ipd: No