<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/NCT04497181</url>
  </required_header>
  <id_info>
    <org_study_id>I2017001223</org_study_id>
    <nct_id>NCT04497181</nct_id>
  </id_info>
  <brief_title>Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization</brief_title>
  <official_title>Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Study on the effectiveness and safety of the coil system for the treatment of intracranial&#xD;
      aneurysms embolization&quot; was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The&#xD;
      trial design is: prospective, multi-center, randomized, open, parallel positive control, and&#xD;
      non-inferiority test. Purpose: To compare the data obtained by using the coil system produced&#xD;
      by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by&#xD;
      Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and&#xD;
      safety of coil system for intracranial aneurysms embolization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;Study on the effectiveness and safety of the coil system for the treatment of intracranial&#xD;
      aneurysms embolization&quot; was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The&#xD;
      team leader is Shanghai Changhai Hospital and the Second Affiliated Hospital of Zhejiang&#xD;
      University School of Medicine. The trial design is: prospective, multi-center, randomized,&#xD;
      open, parallel positive control, and non-inferiority test. Purpose: To compare the data&#xD;
      obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd.&#xD;
      and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial&#xD;
      aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms&#xD;
      embolization. Sample: 228 cases. The subjects will be randomly assigned to the test group or&#xD;
      the control group, with 114 cases in each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2010</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Embolization success rate</measure>
    <time_frame>6 months</time_frame>
    <description>Embolization success rate at 6-month after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aneurysm recurrence rate</measure>
    <time_frame>6 months</time_frame>
    <description>Aneurysm recurrence rate at 6-month after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coil embolization surgery</intervention_name>
    <description>Embolization of aneurysms with various coils system</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An intracranial aneurysm was diagnosed by DSA examination of whole cerebral blood&#xD;
             vessels, and it is planned to use a coil for the embolization of the target aneurysm&#xD;
&#xD;
          -  The subject can understand the purpose of the research, show sufficient compliance&#xD;
             with the research protocol, and sign an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple aneurysms&#xD;
&#xD;
          -  Blood alveolar aneurysm, fusiform aneurysm, pseudoaneurysm, dissecting aneurysm,&#xD;
             infectious aneurysm with arteriovenous malformation&#xD;
&#xD;
          -  mRS score ≥ 3&#xD;
&#xD;
          -  Hunt and Hess rating≥4&#xD;
&#xD;
          -  Emergency ruptured aneurysms who need stent&#xD;
&#xD;
          -  The target aneurysm has previously been treated with vascular embolization or surgery&#xD;
&#xD;
          -  Patients with severe stenosis of the tumor-bearing artery&#xD;
&#xD;
          -  PLT&lt;60*10⁹ or INR&gt;1.5&#xD;
&#xD;
          -  Having vital organ failure or other serious diseases&#xD;
&#xD;
          -  Received major surgery within 30 days before enrollment, or planned to undergo surgery&#xD;
             within 90 days after enrollment&#xD;
&#xD;
          -  History of allergy or contraindications to antiplatelet drugs, anticoagulant drugs,&#xD;
             anesthetics, or contrast agents&#xD;
&#xD;
          -  Patiens with a history of allergies to platinum and tungsten metals&#xD;
&#xD;
          -  Life expectancy &lt;12 months&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Participated in other drug or device clinical trials within 1 month before signing the&#xD;
             informed consent&#xD;
&#xD;
          -  Other situations that the researcher judges are not suitable for inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jianmin zhang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of neurosurgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>jianmin zhang, M.D.</last_name>
    <phone>+86 0571 87784755</phone>
    <email>zjm135@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jianmin Zhang</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianmin Zhang, M.D., Ph.D.</last_name>
      <phone>+86 0571 87784755.</phone>
      <email>zjm135@zju.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Jianmin Zhang, M.D.，Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intracranial aneurysms embolization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04497181
org study id: I2017001223
nct id: NCT04497181
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
"Study on the effectiveness and safety of the coil system for the treatment of intracranial
      aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The
      trial design is: prospective, multi-center, randomized, open, parallel positive control, and
      non-inferiority test. Purpose: To compare the data obtained by using the coil system produced
      by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by
      Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and
      safety of coil system for intracranial aneurysms embolization.
"Study on the effectiveness and safety of the coil system for the treatment of intracranial
      aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The
      team leader is Shanghai Changhai Hospital and the Second Affiliated Hospital of Zhejiang
      University School of Medicine. The trial design is: prospective, multi-center, randomized,
      open, parallel positive control, and non-inferiority test. Purpose: To compare the data
      obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd.
      and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial
      aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms
      embolization. Sample: 228 cases. The subjects will be randomly assigned to the test group or
      the control group, with 114 cases in each group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Embolization success rate
time frame: 6 months
description: Embolization success rate at 6-month after surgery
measure: Aneurysm recurrence rate
time frame: 6 months
description: Aneurysm recurrence rate at 6-month after surgery
arm group label: Experimental group
arm group type: Experimental
arm group label: Control group
arm group type: Sham Comparator
intervention type: Device
intervention name: Coil embolization surgery
description: Embolization of aneurysms with various coils system
arm group label: Control group
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: jianmin zhang, M.D.
role: Principal Investigator
affiliation: Department of neurosurgery
last name: jianmin zhang, M.D.
phone: +86 0571 87784755
email: zjm135@zju.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm