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)
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Morbidity due to neurological adverse events of interest (short-term)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Medical records from patients that have not received a Pipeline™ Flex Embolization Device with Shield Technology™ to treat an intracranial aneurysm
结局指标
主要结局
Morbidity due to neurological adverse events of interest (short-term)
时间窗: 30 days
Prevalence of neurological adverse events of interest post procedure
Mortality due to stroke (long-term)
时间窗: 12 months
Number of deaths due to ischaemic and haemorrhagic post procedure
Prevalence of stroke (short-term)
时间窗: 30 days
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Prevalence of stroke (long-term)
时间窗: 12 months
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Mortality due to stroke (short-term)
时间窗: 30 days
Number of deaths due to ischaemic and haemorrhagic post procedure
Morbidity due to neurological adverse events of interest (long-term)
时间窗: 12 months
Prevalence of neurological adverse events of interest post procedure
Mortality due to neurological adverse events of interest (long-term)
时间窗: 12 months
Deaths due to other neurological adverse events of interest
All cause mortality
时间窗: 12 months
Deaths due to any cause
次要结局
- Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)(6 months)
- Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)(12 months)
- Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)(12 months)
- Aneurysm occlusion - In-stent stenosis (ISS; short-term)(90 days)
- Aneurysm occlusion - Wall apposition(Day 0)
- Aneurysm occlusion - In-stent stenosis (ISS; long-term)(12 months)
- Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)(6 months)
- Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)(12 months)
- Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)(6 months)