<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/NCT03831672</url>
  </required_header>
  <id_info>
    <org_study_id>KY2018-098-01</org_study_id>
    <nct_id>NCT03831672</nct_id>
  </id_info>
  <brief_title>Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China</brief_title>
  <acronym>PLUS</acronym>
  <official_title>Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China (PLUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Neurosurgical Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Group of Brain Doctors</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University International Hospital</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>First Affiliated Hospital of Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Neurosurgical Institute</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>
      Pipeline TM embolization device launched to China in 2014, and has been widely used to treat&#xD;
      large width IA. Therefore, it is necessary to collect and analysis the clinical data to&#xD;
      evaluate effectiveness and safety of its usage in Chinese population, and this may guide the&#xD;
      clinical practice and meet the clinical needs better.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent years, the rapid development of endovascular treatment, especially the introduction of&#xD;
      blood flow diverter device, has led to a new step in the treatment of intracranial aneurysms.&#xD;
      It is different from usual treatment concept, blood flow diverter device's innovation is&#xD;
      guiding to its parent artery reconstruction by cutting into the blood flow velocity and flow&#xD;
      rate to the IA, and, promote the forming of aneurysm cavity thrombosis and the Neointima&#xD;
      growth of IA's neck, so that to achieve aneurysm treatment.&#xD;
&#xD;
      A number of multi-center clinical studies on Pipeline embolization devices (PED, Ev3&#xD;
      Company/Medtronic, USA) have been conducted in North America and Europe recently. Becske etc&#xD;
      reported the result of one multi-center prospective clinical trial of North America (PUFS),&#xD;
      the PED treats the complicated intracranial internal carotid artery aneurysm. At the time of&#xD;
      180 days, 1 year, 3 years follow-up, the complete occlusion rate were 73.6%, 86.8% and 93.4%&#xD;
      respectively. O 'kelly etc. the study showed that the rate of subtotal occlusion over 1 year&#xD;
      follow-up of PED treatment for complex intracranial aneurysms was 90%. Many studies have&#xD;
      confirmed the effectiveness of PED in the treatment of complex intracranial aneurysms.&#xD;
&#xD;
      The main motivation to innovate the blood flow diverter device is to use it to treat some&#xD;
      large or giant aneurysms, fusiform aneurysm which can't be treated well by ordinary&#xD;
      interventional embolization methods. So, in the initial stage of the application, its&#xD;
      indications are mainly focus on the large or giant aneurysms located in the internal carotid&#xD;
      artery before the origin of the posterior communicating artery. In recent years, the blood&#xD;
      flow diverter devices were already used to treat many kinds of IA in almost all parts of the&#xD;
      brain, different sizes and with pathological changes, such as dissecting aneurysms and&#xD;
      vesicular aneurysms.&#xD;
&#xD;
      Although there was already much clinical research evidence which proved the efficacy and&#xD;
      safety of PipelineTM 's treatment to the aneurysm as the embolization device, but these data&#xD;
      are all from the foreign population, there is still no published clinical evidence of large&#xD;
      sample size clinical study of Chinese population. Pipeline has been widely used to treat&#xD;
      large width IA. Therefore, it's meaningful to evaluate effectiveness and safety in Chinese&#xD;
      population, and this may guide the clinical practice and meet the clinical needs better.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of complete aneurysm occlusion in 12 months</measure>
    <time_frame>assessed at 12 months (plus or minus 3 months) after procedure</time_frame>
    <description>Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of ipsilateral major stroke or neurovascular death in 12 months</measure>
    <time_frame>assessed at 12 months (plus or minus 3 months) after procedure</time_frame>
    <description>Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Complete aneurysm occlusion in 6 months</measure>
    <time_frame>assessed at 6 months (plus or minus 3 months) after procedure</time_frame>
    <description>Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Complete aneurysm occlusion in 24 months</measure>
    <time_frame>assessed at 24 months (plus or minus 6 months) after procedure</time_frame>
    <description>Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of ipsilateral major stroke or neurovascular death in 1 month</measure>
    <time_frame>assessed at 1 month (plus or minus 0.5 month) after procedure</time_frame>
    <description>Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-related neurologic adverse event in 12 months</measure>
    <time_frame>assessed at 12 months (plus or minus 3 months) after procedure</time_frame>
    <description>Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of ipsilateral major stroke or neurovascular death in 24 months</measure>
    <time_frame>assessed at 24 months (plus or minus 6 months) after procedure</time_frame>
    <description>Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <condition>Pipeline Embolization Device</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The trial is intended to conduct in 13 centers in China. The sample size of this study was&#xD;
        calculated based on the embolization rate of aneurysm. According to the existing overseas&#xD;
        research data, we assume that the one-year embolization rate of Pipeline treatment for&#xD;
        aneurysms is about 70%. Under the condition that the allowable error is 10% and the&#xD;
        inspection level is 0.05, 162 cases are needed in this study. Considering the heterogeneity&#xD;
        of different centers, the further expanded sample size is 200 cases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients accepting to participate the study&#xD;
&#xD;
          -  Patients treated with Pipeline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated by parent vessel occlusion&#xD;
&#xD;
          -  Patients treated by other stent&#xD;
&#xD;
          -  Patients lacking 3-dimensional aneurysm images or the images not satisfied the&#xD;
             simulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinjian Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Neurosurgical Institute and Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xinjian Yang, MD</last_name>
    <phone>+86-010-59978852</phone>
    <email>yang-xj@163.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jian Liu, MD</last_name>
    <phone>+86-010-59978852</phone>
    <email>jianliu_ns@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinjian Yang, MD</last_name>
      <phone>+86-010-59978852</phone>
      <email>yangxinjian@bjttyy.org</email>
    </contact>
    <contact_backup>
      <last_name>Jian Liu, MD</last_name>
      <phone>+86-010-59978852</phone>
      <email>jianliu_ns@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Xinjian Yang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Neurosurgical Institute</investigator_affiliation>
    <investigator_full_name>Xinjian Yang, MD</investigator_full_name>
    <investigator_title>Vice Chair of Department of Interventional Neuroradiology</investigator_title>
  </responsible_party>
  <keyword>intracranial aneurysm</keyword>
  <keyword>outcome</keyword>
  <keyword>occlusion</keyword>
  <keyword>Pipeline embolization device</keyword>
  <keyword>endovascular treatment</keyword>
  <keyword>flow diversion</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>
  <pending_results>
    <submitted>January 12, 2021</submitted>
    <returned>February 5, 2021</returned>
  </pending_results>
  <!-- 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/NCT03831672
org study id: KY2018-098-01
nct id: NCT03831672
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Pipeline TM embolization device launched to China in 2014, and has been widely used to treat
      large width IA. Therefore, it is necessary to collect and analysis the clinical data to
      evaluate effectiveness and safety of its usage in Chinese population, and this may guide the
      clinical practice and meet the clinical needs better.
Recent years, the rapid development of endovascular treatment, especially the introduction of
      blood flow diverter device, has led to a new step in the treatment of intracranial aneurysms.
      It is different from usual treatment concept, blood flow diverter device's innovation is
      guiding to its parent artery reconstruction by cutting into the blood flow velocity and flow
      rate to the IA, and, promote the forming of aneurysm cavity thrombosis and the Neointima
      growth of IA's neck, so that to achieve aneurysm treatment.

      A number of multi-center clinical studies on Pipeline embolization devices (PED, Ev3
      Company/Medtronic, USA) have been conducted in North America and Europe recently. Becske etc
      reported the result of one multi-center prospective clinical trial of North America (PUFS),
      the PED treats the complicated intracranial internal carotid artery aneurysm. At the time of
      180 days, 1 year, 3 years follow-up, the complete occlusion rate were 73.6%, 86.8% and 93.4%
      respectively. O 'kelly etc. the study showed that the rate of subtotal occlusion over 1 year
      follow-up of PED treatment for complex intracranial aneurysms was 90%. Many studies have
      confirmed the effectiveness of PED in the treatment of complex intracranial aneurysms.

      The main motivation to innovate the blood flow diverter device is to use it to treat some
      large or giant aneurysms, fusiform aneurysm which can't be treated well by ordinary
      interventional embolization methods. So, in the initial stage of the application, its
      indications are mainly focus on the large or giant aneurysms located in the internal carotid
      artery before the origin of the posterior communicating artery. In recent years, the blood
      flow diverter devices were already used to treat many kinds of IA in almost all parts of the
      brain, different sizes and with pathological changes, such as dissecting aneurysms and
      vesicular aneurysms.

      Although there was already much clinical research evidence which proved the efficacy and
      safety of PipelineTM 's treatment to the aneurysm as the embolization device, but these data
      are all from the foreign population, there is still no published clinical evidence of large
      sample size clinical study of Chinese population. Pipeline has been widely used to treat
      large width IA. Therefore, it's meaningful to evaluate effectiveness and safety in Chinese
      population, and this may guide the clinical practice and meet the clinical needs better.
observational model: Other
time perspective: Retrospective
measure: Rate of complete aneurysm occlusion in 12 months
time frame: assessed at 12 months (plus or minus 3 months) after procedure
description: Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
measure: Occurrence of ipsilateral major stroke or neurovascular death in 12 months
time frame: assessed at 12 months (plus or minus 3 months) after procedure
description: Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
measure: Rate of Complete aneurysm occlusion in 6 months
time frame: assessed at 6 months (plus or minus 3 months) after procedure
description: Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
measure: Rate of Complete aneurysm occlusion in 24 months
time frame: assessed at 24 months (plus or minus 6 months) after procedure
description: Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
measure: Occurrence of ipsilateral major stroke or neurovascular death in 1 month
time frame: assessed at 1 month (plus or minus 0.5 month) after procedure
description: Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
measure: Device-related neurologic adverse event in 12 months
time frame: assessed at 12 months (plus or minus 3 months) after procedure
description: Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
measure: Occurrence of ipsilateral major stroke or neurovascular death in 24 months
time frame: assessed at 24 months (plus or minus 6 months) after procedure
description: Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xinjian Yang, MD
role: Principal Investigator
affiliation: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
last name: Xinjian Yang, MD
phone: +86-010-59978852
email: yang-xj@163.net
last name: Jian Liu, MD
phone: +86-010-59978852
email: jianliu_ns@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Neurosurgical Institute
investigator full name: Xinjian Yang, MD
investigator title: Vice Chair of Department of Interventional Neuroradiology
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
submitted: January 12, 2021
returned: February 5, 2021