Stroke, Acute Clinical Trial
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)
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.
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