<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/NCT03815149</url>
  </required_header>
  <id_info>
    <org_study_id>GCMR0002</org_study_id>
    <secondary_id>ISR-2017-10909</secondary_id>
    <nct_id>NCT03815149</nct_id>
  </id_info>
  <brief_title>Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms</brief_title>
  <acronym>SCOPE-AUS</acronym>
  <official_title>The Safety and Clinical Effectiveness of Pipeline™ Flex Embolization Devices With Shield Technology™ in Patients With Intracranial Aneurysms: a Multicentre Retrospective Study of an Australian Cohort (SCOPE-AUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gold Coast Hospital and Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prince of Wales Hospital, Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liverpool Hospital, Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sir Charles Gairdner Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gold Coast Hospital and Health Service</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational, retrospective, single-arm, multi-centre cohort study will use real-world&#xD;
      data (RWD) to develop real-world evidence (RWE) of the safety and clinical effectiveness of&#xD;
      the Pipeline™ Flex Embolization Device with Shield Technology™ in Australian patients that&#xD;
      have received a flow diversion device to treat an intracranial aneurysm (IA). The medical&#xD;
      records from 500 procedures completed at Gold Coast University Hospital in Queensland (QLD),&#xD;
      Prince of Wales Hospital in New South Wales (NSW), and Sir Charles Gardiner Hospital in&#xD;
      Western Australia (WA), will be analysed.&#xD;
&#xD;
      The study will report the risk and likelihood of stroke (ischaemic and haemorrhagic), delayed&#xD;
      neurological adverse events and incomplete aneurysm occlusion within sub-groups of the&#xD;
      patient cohort and determine the predictive or confounding factors that influence clinical&#xD;
      outcomes under pragmatic or 'real-world' conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology summary: Single-arm, longitudinal, retrospective, multi-centre cohort study. A&#xD;
      collaboration of Australian Interventional Neuroradiologists will create a data bank of&#xD;
      existing clinical and angiographic data extracted from medical records review. The data&#xD;
      collection variables are pre-specified using grading scales and clinical assessment with the&#xD;
      greatest reliability or significant to to accurately represent patient cohorts receiving&#xD;
      treatment within all indications of use. The study will establish a minimum dataset to&#xD;
      collect patient socio-demographics, aneurysm characteristics, device characteristics, and&#xD;
      clinical outcomes for up to 500 procedures completed using Pipeline™ Flex Embolization Device&#xD;
      with Shield Technology™. A framework for data ab The prevalence, severity and outcomes of&#xD;
      neurological adverse events of interest and bleeding events will be reported . Independent&#xD;
      physician assessments of complete aneurysm occlusion from completed computed tomography scans&#xD;
      (CT), Magnetic Resonance Imaging (MRI) scans and Digital Subtraction Angiography (DSA)&#xD;
      procedures will be determined according to the Raymond Roy Occlusion Classification (MRRC),&#xD;
      O'Kelly Marotta scale (OKM) for aneurysm occlusion using flow diverting devices and the&#xD;
      Consensus grading scale for endovascular aneurysm occlusion up to 12 months post procedure.&#xD;
      Assessments of wall apposition and in-stent stenosis (ISS) will also be completed.&#xD;
&#xD;
      Quality Assurance plan includes - Framework data abstraction - manual of procedures, data&#xD;
      dictionary, data abstraction manual, desired inter-rater reliability +0.80; intrarater&#xD;
      reliability, intraclass correlation coefficient (ICC) 0.75 - 0.9;&#xD;
&#xD;
      Medical imaging review assessed by assess aneurysm occlusion by an independent interventional&#xD;
      neuroradiologist or a local physician operator that did not complete the primary procedure.&#xD;
      Physician level of agreement - interrater reliability to be reported;&#xD;
&#xD;
      Independent physician review of all post-op strokes (ischaemic, haemorrhagic) cases to&#xD;
      determine aetiology/mechanism;&#xD;
&#xD;
      Study personnel training; Site visits; remote data monitoring, data audits.&#xD;
&#xD;
      Statistical analysis plan include descriptive statistics and regression models to report&#xD;
      prevalence, mortality, time-to-event analyses and estimations of risk; Counts of medical&#xD;
      records with insufficient data for analysis or where the patient is identified as 'lost&#xD;
      follow-up', this will be reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 30, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of stroke (short-term)</measure>
    <time_frame>30 days</time_frame>
    <description>Prevalence and severity of ischaemic and haemorrhagic stroke post procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality due to stroke (short-term)</measure>
    <time_frame>30 days</time_frame>
    <description>Number of deaths due to ischaemic and haemorrhagic post procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity due to neurological adverse events of interest (short-term)</measure>
    <time_frame>30 days</time_frame>
    <description>Prevalence of neurological adverse events of interest post procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stroke (long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Prevalence and severity of ischaemic and haemorrhagic stroke post procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity due to neurological adverse events of interest (long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Prevalence of neurological adverse events of interest post procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality due to stroke (long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Number of deaths due to ischaemic and haemorrhagic post procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality due to neurological adverse events of interest (long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Deaths due to other neurological adverse events of interest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>12 months</time_frame>
    <description>Deaths due to any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - Wall apposition</measure>
    <time_frame>Day 0</time_frame>
    <description>Proportion of aneurysms with good wall apposition at post-operative time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of aneurysms with Grade 0 - 5 aneurysm occlusion; Grade 0 is complete aneurysm occlusion (better outcome; maximum score) Grade 5 is less than 25% aneurysm occlusion (worse outcome; minimum score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of aneurysms with Grade 0 - 5 aneurysm occlusion; Grade 0 is complete aneurysm occlusion (better outcome; maximum score) Grade 5 is less than 25% aneurysm occlusion (worse outcome; minimum score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of aneurysms with Grade D1 aneurysm occlusion on the O'Kelly Marotta Scale. Grade D1 indicates completed aneurysms occlusion as seen on the arterial phase of the cerebral angiogram due to 0% filling (better outcome; maximum score). Grade A1 represents total filling of the aneurysm (&gt;95%) as seen on the arterial phase of the cerebral angiogram (worse outcome; minimum score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of aneurysms with Grade D1 aneurysm occlusion on the O'Kelly Marotta Scale; Grade D1 indicates completed aneurysms occlusion as seen on the arterial phase of the cerebral angiogram due 0% filling (better outcome; maximum score). Grade A1 represents total filling of the aneurysm (&gt;95%) as seen on the arterial phase of the cerebral angiogram (worse outcome; minimum score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of aneurysms with Class 1 occlusion. Class 1 indicates complete obliteration of the aneurysm neck, representing complete aneurysm occlusion (better outcome; maximum score). Class 3b indicates residual aneurysm with contrast along aneurysm wall, representing substantial blood flow into the aneurysm, poor occlusion of aneurysm neck (worst outcome; minimum score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of aneurysms with Class 1 occlusion. Class 1 indicates complete obliteration of the aneurysm neck, representing complete aneurysm occlusion (better outcome; maximum score). Class 3b indicates residual aneurysm with contrast along aneurysm wall, representing substantial blood flow into the aneurysm, poor occlusion of aneurysm neck (worst outcome; minimum score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - In-stent stenosis (ISS; short-term)</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia. Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - In-stent stenosis (ISS; short-term)</measure>
    <time_frame>90 days</time_frame>
    <description>Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - In-stent stenosis (ISS; long-term)</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm occlusion - In-stent stenosis (ISS; long-term)</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional outcomes - Modified Rankin Scale, nil disability</measure>
    <time_frame>90 days</time_frame>
    <description>Change in mRS from baseline mRS 0-1; mRS is a clinician-reported measure of global disability. Level 0 indicates no disability (better outcome, maximum score). Level 6 indicates death (worst outcome, minimum score).</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional outcomes - Modified Rankin Scale, disability</measure>
    <time_frame>90 days</time_frame>
    <description>Change in mRS from baseline mRS 3-6; mRS is a clinician-reported measure of global disability. Level 0 indicates no disability (better outcome, maximum score). Level 5 indicates severe disability, bedridden, incontinent and requiring nursing care and attention (poor outcome, low score). Level 6 indicates death (worst outcome, minimum score).</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional outcomes - number of days spent in hospital</measure>
    <time_frame>90 days</time_frame>
    <description>mean time in hospital, an intensive care unit, or rehabilitation facility</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional outcomes - home time post stroke</measure>
    <time_frame>90 days</time_frame>
    <description>Number of days spent at home after a post-operative stroke</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural time</measure>
    <time_frame>Day 0</time_frame>
    <description>Time from start to end of the procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Dual anti platelet therapy (DAPT) - Assay values</measure>
    <time_frame>Day 0</time_frame>
    <description>% inhibition - DAPT assay values demonstrating impaired platelet activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding events - The Bleeding Academic Research Consortium</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion, severity and classification of bleeding events</description>
  </other_outcome>
  <other_outcome>
    <measure>Re-treatment procedures</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of aneurysms requiring re-treatment procedures</description>
  </other_outcome>
  <other_outcome>
    <measure>Incomplete aneurysms occlusion</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of aneurysms with incomplete occlusion</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <condition>Cerebral Aneurysm</condition>
  <condition>Subarachnoid Hemorrhage</condition>
  <condition>Stroke, Acute</condition>
  <condition>Cerebral Hemorrhage</condition>
  <condition>Cerebral Stroke</condition>
  <condition>Neurologic Disorder</condition>
  <arm_group>
    <arm_group_label>patients with intracranial aneurysm(s)</arm_group_label>
    <description>Standard of care elective, unscheduled or emergency procedures for the treatment of an unruptured or ruptured intracranial aneurysm(s) using a Pipeline™ Flex Embolization Device(s) with Shield Technology™</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pipeline™ Flex Embolization Device with Shield Technology™</intervention_name>
    <description>Neurointerventional procedures to treat intracranial (cerebral) aneurysms are minimally-invasive procedures performed by Interventional Neuroradiologists. The physician accesses the arterial system through a blood vessel in the groin followed by the insertion of a catheter. Pipeline™ Flex Embolization Device(s) with Shield Technology™,a flow diversion device, is implanted under high-magnification subtraction fluoroscopy, requiring the use of ancillary devices, such as micro-catheters and guidewires to complete the procedure under general anaesthetic. Procedural heparinisation and preloading with dual antiplatelet therapy (DAPT) using acetyl-salicylic acid and P2Y12 inhibitors such as clopidogrel or prasugrel are required.</description>
    <arm_group_label>patients with intracranial aneurysm(s)</arm_group_label>
    <other_name>Neurointerventional procedure</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population is comprised of Australian patients aged ≥ 18 years that have received&#xD;
        Pipeline™ Flex Embolization Devices with Shield Technology™ during a standard of care&#xD;
        procedure to treat an IA. The patient selection period extends from 01 April 2015 to 30&#xD;
        June 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years of age&#xD;
&#xD;
          -  Medical records from patients that have received a Pipeline™ Flex Embolization Device&#xD;
             with Shield Technology™ inclusive of all indications such as an elective procedure,&#xD;
             unscheduled procedure or emergency procedure for an unruptured or ruptured&#xD;
             intracranial aneurysm(s) at each study site&#xD;
&#xD;
          -  Medical records from patients that have received other neurovascular therapies such as&#xD;
             coils, intracranial stents etc. with a Pipeline™ Flex Embolization Device with Shield&#xD;
             Technology™ used as an adjunctive device during the index procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical records from patients that have not received a Pipeline™ Flex Embolization&#xD;
             Device with Shield Technology™ to treat an intracranial aneurysm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henry (Hal) A Rice MBBS FRANZCR</last_name>
    <role>Study Director</role>
    <affiliation>Gold Coast University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laetitia E de Villiers MBCHB FRANZCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gold Coast University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jason D Wenderoth BSc MBBS (Hons 1) FRANZCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prince of Wales Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Albert Chiu MBBS (Hons.) FRANZCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Charles Gardiner Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nathan Manning BApSci, BSci(Hons) MBBS FRANZCR CCINR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC</last_name>
    <phone>+61 7 5687 6447</phone>
    <email>maame.owusu@health.qld.gov.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Henry (Hal) A Rice MBBS FRANZ</last_name>
    <phone>+61 7 5687 4430</phone>
    <email>hal.rice@health.qld.gov.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason D Wenderoth MBBS(Hons 1) FRANZCR</last_name>
    </contact>
    <investigator>
      <last_name>Andrew Cheung BSc MBBS(Hons 1) FRANZCR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nathan Manning BApSci, BSci(Hons), MBBS, FRANZCR CCINR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathan Manning BApSci, BSci(Hons), MBBS, FRANZCR, CCINR FRANZCR</last_name>
    </contact>
    <investigator>
      <last_name>Jason Wenderoth MBBS (Hons 1), FRANZCR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Cheung BSc(Med), MBBS (Hons 1), FRANZCR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital</name>
      <address>
        <city>Gold Coast</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henry (Hal) A Rice MBBS FRANZCR</last_name>
    </contact>
    <contact_backup>
      <last_name>Maame Amma P Owusu RN BSc MNurst NVRN-BC</last_name>
      <phone>+61 7 5687 6447</phone>
      <email>maame.owusu@health.qld.gov.au</email>
    </contact_backup>
    <investigator>
      <last_name>Henry (Hal) A Rice MBBS FRANZCR</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laetitia E de Villiers MBCHB FRANZCR</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Albert Chiu MBBS (Hons) FRANZCR</last_name>
    </contact>
    <investigator>
      <last_name>William McAuliffe MBBS FRANZCR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Timothy Phillips MBBS GDSA FRANZCR CCINR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>December 9, 2019</last_update_submitted>
  <last_update_submitted_qc>December 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interventional Neuroradiology</keyword>
  <keyword>Diagnostic neuroradiology</keyword>
  <keyword>Neurosurgery</keyword>
  <keyword>Neurovascular Devices</keyword>
  <keyword>Flow Diversion Device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>To align with national recommendations for data sharing, the SCOPE-AUS metadata (description of the data) shall be published in a metadata record through Research Data Australia Registry, an entity of the Australian National Data Service. The goal is to ensure that data that is unique to the discipline of Interventional Neuroradiology is available for reuse in future research purposes.&#xD;
The SCOPE-AUS metadata will be available at 12 months following primary publication until 48 months.</ipd_time_frame>
    <ipd_access_criteria>Access shall be conditional; re-users must be genuine researchers whose proposed use of the data has been approved by an Ethics committee. Re-users are required to cite the SCOPE-AUS dataset in any scholarly outputs. This proposed strategy will uphold Australian privacy laws. The Sponsor/Coordinating Principal Investigator/SCOPE-AUS research team will ultimately retain oversight of all future uses of the data.</ipd_access_criteria>
    <ipd_url>https://researchdata.ands.org.au/</ipd_url>
  </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/NCT03815149
org study id: GCMR0002
secondary id: ISR-2017-10909
nct id: NCT03815149
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This observational, retrospective, single-arm, multi-centre cohort study will use real-world
      data (RWD) to develop real-world evidence (RWE) of the safety and clinical effectiveness of
      the Pipeline™ Flex Embolization Device with Shield Technology™ in Australian patients that
      have received a flow diversion device to treat an intracranial aneurysm (IA). The medical
      records from 500 procedures completed at Gold Coast University Hospital in Queensland (QLD),
      Prince of Wales Hospital in New South Wales (NSW), and Sir Charles Gardiner Hospital in
      Western Australia (WA), will be analysed.

      The study will report the risk and likelihood of stroke (ischaemic and haemorrhagic), delayed
      neurological adverse events and incomplete aneurysm occlusion within sub-groups of the
      patient cohort and determine the predictive or confounding factors that influence clinical
      outcomes under pragmatic or 'real-world' conditions.
Methodology summary: Single-arm, longitudinal, retrospective, multi-centre cohort study. A
      collaboration of Australian Interventional Neuroradiologists will create a data bank of
      existing clinical and angiographic data extracted from medical records review. The data
      collection variables are pre-specified using grading scales and clinical assessment with the
      greatest reliability or significant to to accurately represent patient cohorts receiving
      treatment within all indications of use. The study will establish a minimum dataset to
      collect patient socio-demographics, aneurysm characteristics, device characteristics, and
      clinical outcomes for up to 500 procedures completed using Pipeline™ Flex Embolization Device
      with Shield Technology™. A framework for data ab The prevalence, severity and outcomes of
      neurological adverse events of interest and bleeding events will be reported . Independent
      physician assessments of complete aneurysm occlusion from completed computed tomography scans
      (CT), Magnetic Resonance Imaging (MRI) scans and Digital Subtraction Angiography (DSA)
      procedures will be determined according to the Raymond Roy Occlusion Classification (MRRC),
      O'Kelly Marotta scale (OKM) for aneurysm occlusion using flow diverting devices and the
      Consensus grading scale for endovascular aneurysm occlusion up to 12 months post procedure.
      Assessments of wall apposition and in-stent stenosis (ISS) will also be completed.

      Quality Assurance plan includes - Framework data abstraction - manual of procedures, data
      dictionary, data abstraction manual, desired inter-rater reliability +0.80; intrarater
      reliability, intraclass correlation coefficient (ICC) 0.75 - 0.9;

      Medical imaging review assessed by assess aneurysm occlusion by an independent interventional
      neuroradiologist or a local physician operator that did not complete the primary procedure.
      Physician level of agreement - interrater reliability to be reported;

      Independent physician review of all post-op strokes (ischaemic, haemorrhagic) cases to
      determine aetiology/mechanism;

      Study personnel training; Site visits; remote data monitoring, data audits.

      Statistical analysis plan include descriptive statistics and regression models to report
      prevalence, mortality, time-to-event analyses and estimations of risk; Counts of medical
      records with insufficient data for analysis or where the patient is identified as 'lost
      follow-up', this will be reported.
observational model: Cohort
time perspective: Retrospective
measure: Prevalence of stroke (short-term)
time frame: 30 days
description: Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
measure: Mortality due to stroke (short-term)
time frame: 30 days
description: Number of deaths due to ischaemic and haemorrhagic post procedure
measure: Morbidity due to neurological adverse events of interest (short-term)
time frame: 30 days
description: Prevalence of neurological adverse events of interest post procedure
measure: Prevalence of stroke (long-term)
time frame: 12 months
description: Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
measure: Morbidity due to neurological adverse events of interest (long-term)
time frame: 12 months
description: Prevalence of neurological adverse events of interest post procedure
measure: Mortality due to stroke (long-term)
time frame: 12 months
description: Number of deaths due to ischaemic and haemorrhagic post procedure
measure: Mortality due to neurological adverse events of interest (long-term)
time frame: 12 months
description: Deaths due to other neurological adverse events of interest
measure: All cause mortality
time frame: 12 months
description: Deaths due to any cause
measure: Aneurysm occlusion - Wall apposition
time frame: Day 0
description: Proportion of aneurysms with good wall apposition at post-operative time point
measure: Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)
time frame: 6 months
description: Proportion of aneurysms with Grade 0 - 5 aneurysm occlusion; Grade 0 is complete aneurysm occlusion (better outcome; maximum score) Grade 5 is less than 25% aneurysm occlusion (worse outcome; minimum score)
measure: Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)
time frame: 12 months
description: Proportion of aneurysms with Grade 0 - 5 aneurysm occlusion; Grade 0 is complete aneurysm occlusion (better outcome; maximum score) Grade 5 is less than 25% aneurysm occlusion (worse outcome; minimum score)
measure: Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)
time frame: 6 months
description: Proportion of aneurysms with Grade D1 aneurysm occlusion on the O'Kelly Marotta Scale. Grade D1 indicates completed aneurysms occlusion as seen on the arterial phase of the cerebral angiogram due to 0% filling (better outcome; maximum score). Grade A1 represents total filling of the aneurysm (>95%) as seen on the arterial phase of the cerebral angiogram (worse outcome; minimum score).
measure: Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)
time frame: 12 months
description: Proportion of aneurysms with Grade D1 aneurysm occlusion on the O'Kelly Marotta Scale; Grade D1 indicates completed aneurysms occlusion as seen on the arterial phase of the cerebral angiogram due 0% filling (better outcome; maximum score). Grade A1 represents total filling of the aneurysm (>95%) as seen on the arterial phase of the cerebral angiogram (worse outcome; minimum score).
measure: Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)
time frame: 6 months
description: Proportion of aneurysms with Class 1 occlusion. Class 1 indicates complete obliteration of the aneurysm neck, representing complete aneurysm occlusion (better outcome; maximum score). Class 3b indicates residual aneurysm with contrast along aneurysm wall, representing substantial blood flow into the aneurysm, poor occlusion of aneurysm neck (worst outcome; minimum score).
measure: Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)
time frame: 12 months
description: Proportion of aneurysms with Class 1 occlusion. Class 1 indicates complete obliteration of the aneurysm neck, representing complete aneurysm occlusion (better outcome; maximum score). Class 3b indicates residual aneurysm with contrast along aneurysm wall, representing substantial blood flow into the aneurysm, poor occlusion of aneurysm neck (worst outcome; minimum score).
measure: Aneurysm occlusion - In-stent stenosis (ISS; short-term)
time frame: 30 days
description: Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia. Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
measure: Aneurysm occlusion - In-stent stenosis (ISS; short-term)
time frame: 90 days
description: Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
measure: Aneurysm occlusion - In-stent stenosis (ISS; long-term)
time frame: 6 months
description: Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
measure: Aneurysm occlusion - In-stent stenosis (ISS; long-term)
time frame: 12 months
description: Proportion of aneurysms with Grade 2-4 ISS; ISS is a focal area of parent cerebral vessel narrowing caused by thrombosis or intimal hypoplasia.Grade 0 indicates no ISS is present (better outcome, maximum score). Grade 4 indicates occlusion of the cerebral parent vessel (worst outcome, minimum score).
measure: Functional outcomes - Modified Rankin Scale, nil disability
time frame: 90 days
description: Change in mRS from baseline mRS 0-1; mRS is a clinician-reported measure of global disability. Level 0 indicates no disability (better outcome, maximum score). Level 6 indicates death (worst outcome, minimum score).
measure: Functional outcomes - Modified Rankin Scale, disability
time frame: 90 days
description: Change in mRS from baseline mRS 3-6; mRS is a clinician-reported measure of global disability. Level 0 indicates no disability (better outcome, maximum score). Level 5 indicates severe disability, bedridden, incontinent and requiring nursing care and attention (poor outcome, low score). Level 6 indicates death (worst outcome, minimum score).
measure: Functional outcomes - number of days spent in hospital
time frame: 90 days
description: mean time in hospital, an intensive care unit, or rehabilitation facility
measure: Functional outcomes - home time post stroke
time frame: 90 days
description: Number of days spent at home after a post-operative stroke
measure: Procedural time
time frame: Day 0
description: Time from start to end of the procedure
measure: Dual anti platelet therapy (DAPT) - Assay values
time frame: Day 0
description: % inhibition - DAPT assay values demonstrating impaired platelet activity
measure: Bleeding events - The Bleeding Academic Research Consortium
time frame: 12 months
description: Proportion, severity and classification of bleeding events
measure: Re-treatment procedures
time frame: 12 months
description: Proportion of aneurysms requiring re-treatment procedures
measure: Incomplete aneurysms occlusion
time frame: 12 months
description: Proportion of aneurysms with incomplete occlusion
arm group label: patients with intracranial aneurysm(s)
description: Standard of care elective, unscheduled or emergency procedures for the treatment of an unruptured or ruptured intracranial aneurysm(s) using a Pipeline™ Flex Embolization Device(s) with Shield Technology™
intervention type: Device
intervention name: Pipeline™ Flex Embolization Device with Shield Technology™
description: Neurointerventional procedures to treat intracranial (cerebral) aneurysms are minimally-invasive procedures performed by Interventional Neuroradiologists. The physician accesses the arterial system through a blood vessel in the groin followed by the insertion of a catheter. Pipeline™ Flex Embolization Device(s) with Shield Technology™,a flow diversion device, is implanted under high-magnification subtraction fluoroscopy, requiring the use of ancillary devices, such as micro-catheters and guidewires to complete the procedure under general anaesthetic. Procedural heparinisation and preloading with dual antiplatelet therapy (DAPT) using acetyl-salicylic acid and P2Y12 inhibitors such as clopidogrel or prasugrel are required.
arm group label: patients with intracranial aneurysm(s)
other name: Neurointerventional procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Henry (Hal) A Rice MBBS FRANZCR
role: Study Director
affiliation: Gold Coast University Hospital
last name: Laetitia E de Villiers MBCHB FRANZCR
role: Principal Investigator
affiliation: Gold Coast University Hospital
last name: Jason D Wenderoth BSc MBBS (Hons 1) FRANZCR
role: Principal Investigator
affiliation: Prince of Wales Hospital
last name: Albert Chiu MBBS (Hons.) FRANZCR
role: Principal Investigator
affiliation: Sir Charles Gardiner Hospital
last name: Nathan Manning BApSci, BSci(Hons) MBBS FRANZCR CCINR
role: Principal Investigator
affiliation: Liverpool Hospital
last name: Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC
phone: +61 7 5687 6447
email: maame.owusu@health.qld.gov.au
last name: Henry (Hal) A Rice MBBS FRANZ
phone: +61 7 5687 4430
email: hal.rice@health.qld.gov.au
facility: 
status: Recruiting
contact: 
investigator: 
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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country: Australia
responsible party type: Sponsor
mesh term: Stroke
mesh term: Subarachnoid Hemorrhage
mesh term: Intracranial Aneurysm
mesh term: Cerebral Hemorrhage
mesh term: Nervous System Diseases
mesh term: Aneurysm
mesh term: Hemorrhage
sharing ipd: Yes
ipd description: This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: To align with national recommendations for data sharing, the SCOPE-AUS metadata (description of the data) shall be published in a metadata record through Research Data Australia Registry, an entity of the Australian National Data Service. The goal is to ensure that data that is unique to the discipline of Interventional Neuroradiology is available for reuse in future research purposes.
The SCOPE-AUS metadata will be available at 12 months following primary publication until 48 months.
ipd access criteria: Access shall be conditional; re-users must be genuine researchers whose proposed use of the data has been approved by an Ethics committee. Re-users are required to cite the SCOPE-AUS dataset in any scholarly outputs. This proposed strategy will uphold Australian privacy laws. The Sponsor/Coordinating Principal Investigator/SCOPE-AUS research team will ultimately retain oversight of all future uses of the data.
ipd url: https://researchdata.ands.org.au/