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 Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ 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.
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Prevalence of stroke (short-term)
Timeframe: 30 days
Mortality due to stroke (short-term)
Timeframe: 30 days
Morbidity due to neurological adverse events of interest (short-term)
Timeframe: 30 days
Prevalence of stroke (long-term)
Timeframe: 12 months
Morbidity due to neurological adverse events of interest (long-term)
Timeframe: 12 months
Mortality due to stroke (long-term)
Timeframe: 12 months
Mortality due to neurological adverse events of interest (long-term)
Timeframe: 12 months
All cause mortality
Timeframe: 12 months
Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC