<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/NCT02998229</url>
  </required_header>
  <id_info>
    <org_study_id>COVARTS0571</org_study_id>
    <nct_id>NCT02998229</nct_id>
  </id_info>
  <brief_title>Aneurysm Treatment Using Intrasaccular Flow Diversion With the ARTISSE™ Device</brief_title>
  <acronym>ARTISSE</acronym>
  <official_title>ARTISSE Aneurysm Treatment Using Intrasaccular Flow Diversion With the ARTISSE™ Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Neurovascular Clinical Affairs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Neurovascular Clinical Affairs</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and effectiveness of the Artisse™&#xD;
      Intrasaccular Device in the treatment of bifurcating saccular intracranial aneurysms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 2023</start_date>
  <completion_date type="Anticipated">November 2026</completion_date>
  <primary_completion_date type="Anticipated">October 2026</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>Incidence of complete aneurysm occlusion without retreatment, recurrent SAH, and without significant parent artery stenosis</measure>
    <time_frame>1 year post procedure</time_frame>
    <description>Significant parent artery stenosis defined as stenosis of the parent artery associated with stroke or total occlusion of the artery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of major stroke or neurological death</measure>
    <time_frame>1 year post procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of successful device implantation</measure>
    <time_frame>Implant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adequate aneurysm occlusion</measure>
    <time_frame>1 year post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of unruptured aneurysm subjects with modified Rankin Score (mRS) of 0-2 or no increase in the mRS</measure>
    <time_frame>1 year post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major stroke in the territory supplied by the treated artery or neurological death</measure>
    <time_frame>30 days post procedure</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Procedure time</measure>
    <time_frame>at procedure</time_frame>
    <description>Time of guiding catheter entry to the time of guiding catheter removal</description>
  </other_outcome>
  <other_outcome>
    <measure>Radiation Exposure</measure>
    <time_frame>at procedure</time_frame>
    <description>dosage and cumulative fluoroscopy time</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of recurrence of the target aneurysm</measure>
    <time_frame>1 year post procedure</time_frame>
    <description>Web Occlusion Grade C or D at any time after achieving a complete occlusion grade of A immediately post procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of retreatment</measure>
    <time_frame>1 year post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of aneurysm rupture</measure>
    <time_frame>1 year post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of intracranial hemorrhage (excluding target aneurysm)</measure>
    <time_frame>1 year post procedure</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <arm_group>
    <arm_group_label>Artisse™ Intrasaccular Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Artisse™</intervention_name>
    <description>Intrasaccular Device</description>
    <arm_group_label>Artisse™ Intrasaccular Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided written informed consent using the IRB/EC-approved consent form&#xD;
             and agrees to comply with protocol requirements.&#xD;
&#xD;
          -  Subject is at least 22 years old at the time of consent.&#xD;
&#xD;
          -  Subject has a ruptured or unruptured, wide neck, bifurcating saccular intracranial&#xD;
             aneurysm (IA) requiring endovascular treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has more than one aneurysm requiring treatment.&#xD;
&#xD;
          -  Subject underwent treatment of another aneurysm inside the affected territory of the&#xD;
             target aneurysm.&#xD;
&#xD;
          -  Aneurysm is partially thrombosed.&#xD;
&#xD;
          -  Aneurysm has been previously treated with surgery or endovascular therapy, or there is&#xD;
             a stent or other obstruction in the parent artery at the target aneurysm location.&#xD;
&#xD;
          -  Subject has had subarachnoid hemorrhage (SAH) from non target aneurysm or any other&#xD;
             intracranial hemorrhage within 90 days prior to study procedure.&#xD;
&#xD;
          -  Subject vessel has characteristics that preclude safe endovascular access.&#xD;
&#xD;
          -  Subject has active vasospasm, malignant brain tumor or vascular malformation (e.g.&#xD;
             arteriovascular malformation).&#xD;
&#xD;
          -  Subject has had major surgery including endovascular procedures within the past 30&#xD;
             days prior to study procedure.&#xD;
&#xD;
          -  Subject has a life expectancy of &lt; 12 months.&#xD;
&#xD;
          -  The Investigator determines that the health of the subject or the validity of the&#xD;
             study outcomes (e.g., high risk of neurologic events, conditions that may increase the&#xD;
             chance of stroke) may be compromised by the subject's enrollment.&#xD;
&#xD;
          -  Subject is pregnant or wishes to become pregnant during the length of study&#xD;
             participation.&#xD;
&#xD;
          -  Subject is participating in another clinical trial at any time during the duration of&#xD;
             the study that could confound the treatment or outcomes of this investigation.&#xD;
             Co-enrollment in concurrent trials is only allowed when documented pre-approval is&#xD;
             obtained from Medtronic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Medtronic Neurovascular Clinical Affairs</last_name>
    <phone>949-837-3700</phone>
    <email>rs.nvclinicalartisse@medtronic.com</email>
  </overall_contact>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</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>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02998229
org study id: COVARTS0571
nct id: NCT02998229
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to assess the safety and effectiveness of the Artisse™
      Intrasaccular Device in the treatment of bifurcating saccular intracranial aneurysms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of complete aneurysm occlusion without retreatment, recurrent SAH, and without significant parent artery stenosis
time frame: 1 year post procedure
description: Significant parent artery stenosis defined as stenosis of the parent artery associated with stroke or total occlusion of the artery
measure: Incidence of major stroke or neurological death
time frame: 1 year post procedure
measure: Incidence of successful device implantation
time frame: Implant
measure: Incidence of adequate aneurysm occlusion
time frame: 1 year post procedure
measure: Incidence of unruptured aneurysm subjects with modified Rankin Score (mRS) of 0-2 or no increase in the mRS
time frame: 1 year post procedure
measure: Incidence of major stroke in the territory supplied by the treated artery or neurological death
time frame: 30 days post procedure
measure: Procedure time
time frame: at procedure
description: Time of guiding catheter entry to the time of guiding catheter removal
measure: Radiation Exposure
time frame: at procedure
description: dosage and cumulative fluoroscopy time
measure: Incidence of recurrence of the target aneurysm
time frame: 1 year post procedure
description: Web Occlusion Grade C or D at any time after achieving a complete occlusion grade of A immediately post procedure
measure: Incidence of retreatment
time frame: 1 year post procedure
measure: Incidence of aneurysm rupture
time frame: 1 year post procedure
measure: Incidence of intracranial hemorrhage (excluding target aneurysm)
time frame: 1 year post procedure
arm group label: Artisse™ Intrasaccular Device
arm group type: Experimental
intervention type: Device
intervention name: Artisse™
description: Intrasaccular Device
arm group label: Artisse™ Intrasaccular Device
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Medtronic Neurovascular Clinical Affairs
phone: 949-837-3700
email: rs.nvclinicalartisse@medtronic.com
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
sharing ipd: No