NCT03815149

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

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Gold Coast Hospital and Health Service · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Intracranial Aneurysm
• Cerebral Aneurysm
• Subarachnoid Hemorrhage
• Stroke, Acute
• Cerebral Hemorrhage
• Cerebral Stroke
• Neurologic Disorder

Interventions

Type	Name	Description
DEVICE	Pipeline™ Flex Embolization Device with Shield Technology™	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.

Timeline

• Start date: 2019-05-30
• Primary completion: 2020-01-30
• Completion: 2020-09-30
• First posted: 2019-01-24
• Last updated: 2019-12-10

Locations

4 sites across 1 country: Australia

Regulatory

• FDA-regulated device study