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