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/NCT05996354</url>
    </required_header>
    <id_info>
      <org_study_id>XJ-PR48-FIM-05</org_study_id>
      <nct_id>NCT05996354</nct_id>
    </id_info>
    <brief_title>Concave Supra-arch Branched Stent-Graft Stent-Graft System for Treatment of Aortic Arch Diseases</brief_title>
    <official_title>A Study on the Concave Supra-arch Branched Stent-Graft Stent-graft System for Treatment of Aortic Arch Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</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>
        There are no endoluminal stent systems available on the Chinese market for the effective&#xD;
        treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic&#xD;
        pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is&#xD;
        intended to be a prospective, single-arm study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The physician shall strictly follow the clinical study protocol and shall not deviate from or&#xD;
        substantially change the protocol. However, in case of emergency such as immediate risk to&#xD;
        the subjects, which needs to be eliminated immediately, it may be reported in written form&#xD;
        afterwards. During the course of the study, documents such as amendments to the clinical&#xD;
        study protocol and informed consent, requests for deviation, and resumption of the suspended&#xD;
        clinical study shall be subject to the written approval of the Ethics Committee.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Immediate technical success rate</measure>
      <time_frame>Immediate intraoperative</time_frame>
      <description>Immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body, and the branch arteries were successfully reconstructed.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Aortic Dissection</condition>
    <condition>Aneurysm, Aortic Arch</condition>
    <condition>Aortic Pseudoaneurysm</condition>
    <condition>Aortic Ulcer, Penetrating</condition>
    <condition>Aortic Intramural Hematoma</condition>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Concave Supra-arch Branched stent-graft system</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Concave Supra-arch Branched stent-graft system</intervention_name>
      <description>To evaluate the efficacy and safety of the Concave Supra-arch Branched stent-graft system for endovascular treatment of aortic arch diseases.</description>
      <arm_group_label>Intervention arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who are ≥ 18 years old and ≤ 85 years old；&#xD;
  &#xD;
            2. Patients with aortic arch diseases (involving aortic arch aneurysm, aortic dissection,&#xD;
               aortic pseudoaneurysm, aortic ulcer, and intermural hematoma);&#xD;
  &#xD;
            3. Anatomical criteria, including:&#xD;
  &#xD;
                 1. Ascending aorta length is greater than or equal to 50 mm (distance from aortic&#xD;
                    sinus to anterior edge of innominate artery);&#xD;
  &#xD;
                 2. The diameter range of the anchoring area at the proximal end of the main body is&#xD;
                    between 25-45 mm and the length is greater than or equal to 15 mm;&#xD;
  &#xD;
                 3. The diameter of the anchored area of the innominate artery is between 10-16 mm,&#xD;
                    the diameter of the anchored area of the left common carotid artery is between&#xD;
                    5-12 mm, and the diameter of the anchored area of the left subclavian artery is&#xD;
                    between 5-12 mm. Anchorage zone length is greater than or equal to 15 mm;&#xD;
  &#xD;
                 4. Distance between the anterior edge of the innominate artery to the posterior edge&#xD;
                    of the left subclavian artery is less than or equal to 80 mm;&#xD;
  &#xD;
                 5. Have a suitable iliac, femoral, and superior arch arterial approach;&#xD;
  &#xD;
            4. Patients who understand the purpose of the study, volunteer to participate and sign&#xD;
               the informed consent form, and are willing to complete follow-up visits as required by&#xD;
               the protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with general or local infections that may increase the risk of endovascular&#xD;
               graft infection;&#xD;
  &#xD;
            2. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring&#xD;
               area, which is likely to make the stent-graft difficult to adhere to or affect the&#xD;
               patency of the stent;&#xD;
  &#xD;
            3. Patients with neck vascular surgery within 3 months;&#xD;
  &#xD;
            4. Patients with severe carotid or subclavian artery stenosis, calcification;&#xD;
  &#xD;
            5. Patients with a history of acute coronary syndrome within 6 months:&#xD;
  &#xD;
               Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture&#xD;
               of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to&#xD;
               the formation of new blood 4 thrombus, including ST-elevation myocardial infarction,&#xD;
               non-ST elevation myocardial infarction, and unstable angina.&#xD;
  &#xD;
            6. Patients with transient ischemic attack (TIA) or ischemic stroke within 3 months;&#xD;
  &#xD;
            7. Patients with preoperative hepatic and renal dysfunction, [alanine aminotransferase&#xD;
               (ALT) or aspartate aminotransferase (AST) exceeded the upper limit of normal level by&#xD;
               a factor of five; Serum creatinine (Cr) &gt;150umol/L];&#xD;
  &#xD;
            8. Patients with history of bleeding or coagulopathy, who cannot receive antiplatelet&#xD;
               therapy;&#xD;
  &#xD;
            9. Patients with severe aortic insufficiency or a history of prior aortic valve&#xD;
               insufficiency treatment;&#xD;
  &#xD;
           10. Patients with a history of hypersensitivity to contrast agents, anticoagulant&#xD;
               antiplatelet agents, stents, delivery equipment materials (i.e., nitinol, polyester,&#xD;
               PTFE, nylon polymer materials);&#xD;
  &#xD;
           11. Patients with connective tissue diseases such as Marfan's syndrome, Egyptian syndrome,&#xD;
               or Behcet's disease;&#xD;
  &#xD;
           12. Patients with arteritis;&#xD;
  &#xD;
           13. Patients with significant organ dysfunction or other serious disease;&#xD;
  &#xD;
           14. Patients with life expectancy of not more than 1 year;&#xD;
  &#xD;
           15. Patients who are not eligible for endovascular treatment per in the investigator's&#xD;
               judgment of the investigator;&#xD;
  &#xD;
           16. Women with planned pregnancy, pregnancy stage , or lactation&#xD;
  &#xD;
           17. The patient participated in another clinical trial and was not out or withdrawn within&#xD;
               the first 3 months of the screening period of this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Chinese Academy of Medical Sciences Fuwai Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Second Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Yunnan Fuwai cardiovascular disease Hospital</name>
        <address>
          <city>YunNan</city>
          <state>Yunnan</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>Aneurysm</mesh_term>
      <mesh_term>Aortic Dissection</mesh_term>
      <mesh_term>Aneurysm, False</mesh_term>
      <mesh_term>Aortic Intramural Hematoma</mesh_term>
      <mesh_term>Aortic Aneurysm</mesh_term>
      <mesh_term>Hematoma</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/NCT05996354
  org study id: XJ-PR48-FIM-05
  nct id: NCT05996354
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  There are no endoluminal stent systems available on the Chinese market for the effective
        treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic
        pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is
        intended to be a prospective, single-arm study.
  The physician shall strictly follow the clinical study protocol and shall not deviate from or
        substantially change the protocol. However, in case of emergency such as immediate risk to
        the subjects, which needs to be eliminated immediately, it may be reported in written form
        afterwards. During the course of the study, documents such as amendments to the clinical
        study protocol and informed consent, requests for deviation, and resumption of the suspended
        clinical study shall be subject to the written approval of the Ethics Committee.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Immediate technical success rate
  time frame: Immediate intraoperative
  description: Immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body, and the branch arteries were successfully reconstructed.
  arm group label: Intervention arm
  arm group type: Experimental
  description: Concave Supra-arch Branched stent-graft system
  intervention type: Device
  intervention name: Concave Supra-arch Branched stent-graft system
  description: To evaluate the efficacy and safety of the Concave Supra-arch Branched stent-graft system for endovascular treatment of aortic arch diseases.
  arm group label: Intervention arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Aneurysm
  mesh term: Aortic Dissection
  mesh term: Aneurysm, False
  mesh term: Aortic Intramural Hematoma
  mesh term: Aortic Aneurysm
  mesh term: Hematoma
  sharing ipd: No