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.
Study Type
OBSERVATIONAL
Enrollment
500
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.
Prince of Wales Hospital
Sydney, New South Wales, Australia
RECRUITINGLiverpool Hospital
Sydney, New South Wales, Australia
RECRUITINGGold Coast University Hospital
Gold Coast, Queensland, Australia
RECRUITINGSir Charles Gairdner Hospital
Perth, Western Australia, Australia
NOT_YET_RECRUITINGPrevalence of stroke (short-term)
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Time frame: 30 days
Mortality due to stroke (short-term)
Number of deaths due to ischaemic and haemorrhagic post procedure
Time frame: 30 days
Morbidity due to neurological adverse events of interest (short-term)
Prevalence of neurological adverse events of interest post procedure
Time frame: 30 days
Prevalence of stroke (long-term)
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Time frame: 12 months
Morbidity due to neurological adverse events of interest (long-term)
Prevalence of neurological adverse events of interest post procedure
Time frame: 12 months
Mortality due to stroke (long-term)
Number of deaths due to ischaemic and haemorrhagic post procedure
Time frame: 12 months
Mortality due to neurological adverse events of interest (long-term)
Deaths due to other neurological adverse events of interest
Time frame: 12 months
All cause mortality
Deaths due to any cause
Time frame: 12 months
Aneurysm occlusion - Wall apposition
Proportion of aneurysms with good wall apposition at post-operative time point
Time frame: Day 0
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)
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)
Time frame: 6 months
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)
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)
Time frame: 12 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)
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).
Time frame: 6 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)
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).
Time frame: 12 months
Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)
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).
Time frame: 6 months
Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)
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).
Time frame: 12 months
Aneurysm occlusion - In-stent stenosis (ISS; short-term)
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).
Time frame: 30 days
Aneurysm occlusion - In-stent stenosis (ISS; short-term)
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).
Time frame: 90 days
Aneurysm occlusion - In-stent stenosis (ISS; long-term)
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).
Time frame: 6 months
Aneurysm occlusion - In-stent stenosis (ISS; long-term)
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).
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.