Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms

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Brief Title

Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms

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)

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Prevalence of stroke (short-term)

Secondary Outcome

 Aneurysm occlusion - Wall apposition

Condition

Intracranial Aneurysm

Intervention

Pipeline™ Flex Embolization Device with Shield Technology™

Study Arms / Comparison Groups

 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™

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

500

Start Date

May 30, 2019

Completion Date

September 30, 2020

Primary Completion Date

January 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients ≥ 18 years of age

          -  Medical records from patients that have received a Pipeline™ Flex Embolization Device
             with Shield Technology™ inclusive of all indications such as an elective procedure,
             unscheduled procedure or emergency procedure for an unruptured or ruptured
             intracranial aneurysm(s) at each study site

          -  Medical records from patients that have received other neurovascular therapies such as
             coils, intracranial stents etc. with a Pipeline™ Flex Embolization Device with Shield
             Technology™ used as an adjunctive device during the index procedure

        Exclusion Criteria:

          -  Medical records from patients that have not received a Pipeline™ Flex Embolization
             Device with Shield Technology™ to treat an intracranial aneurysm
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Henry (Hal) A Rice MBBS FRANZCR, +61 7 5687 6447, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03815149

Organization ID

GCMR0002

Secondary IDs

ISR-2017-10909

Responsible Party

Sponsor

Study Sponsor

Gold Coast Hospital and Health Service

Collaborators

 Prince of Wales Hospital, Sydney

Study Sponsor

Henry (Hal) A Rice MBBS FRANZCR, Study Director, Gold Coast University Hospital


Verification Date

December 2019