Clinical trial NCT03815149: Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Cerebral Aneurysm
Subarachnoid Hemorrhage
Stroke, Acute
Cerebral Hemorrhage
Cerebral Stroke
Neurologic Disorder
Keywords: Interventional Neuroradiology
Diagnostic neuroradiology
Neurosurgery
Neurovascular Devices
Flow Diversion Device
Lead sponsor: Gold Coast Hospital and Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Prince of Wales Hospital, Sydney
name: Liverpool Hospital, Sydney
name: Sir Charles Gairdner Hospital
First posted: 2019-01-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is comprised of Australian patients aged ≥ 18 years that have received Pipeline™ Flex Embolization Devices with Shield Technology™ during a standard of care procedure to treat an IA. The patient selection period extends from 01 April 2015 to 30 June 2018.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Medical records from patients that have not received a Pipeline™ Flex Embolization Device with Shield Technology™ to treat an intracranial aneurysm

Primary outcomes:
measure: Prevalence of stroke (short-term)
timeFrame: 30 days
measure: Mortality due to stroke (short-term)
timeFrame: 30 days
measure: Morbidity due to neurological adverse events of interest (short-term)
timeFrame: 30 days
measure: Prevalence of stroke (long-term)
timeFrame: 12 months
measure: Morbidity due to neurological adverse events of interest (long-term)
timeFrame: 12 months
measure: Mortality due to stroke (long-term)
timeFrame: 12 months
measure: Mortality due to neurological adverse events of interest (long-term)
timeFrame: 12 months
measure: All cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: Aneurysm occlusion - Wall apposition
timeFrame: Day 0
measure: Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)
timeFrame: 6 months
measure: Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)
timeFrame: 12 months
measure: Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)
timeFrame: 6 months
measure: Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)
timeFrame: 12 months
measure: Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)
timeFrame: 6 months
measure: Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)
timeFrame: 12 months
measure: Aneurysm occlusion - In-stent stenosis (ISS; short-term)
timeFrame: 30 days
measure: Aneurysm occlusion - In-stent stenosis (ISS; short-term)
timeFrame: 90 days
measure: Aneurysm occlusion - In-stent stenosis (ISS; long-term)
timeFrame: 6 months
measure: Aneurysm occlusion - In-stent stenosis (ISS; long-term)
timeFrame: 12 months
Other outcomes:
measure: Functional outcomes - Modified Rankin Scale, nil disability
timeFrame: 90 days
measure: Functional outcomes - Modified Rankin Scale, disability
timeFrame: 90 days
measure: Functional outcomes - number of days spent in hospital
timeFrame: 90 days
measure: Functional outcomes - home time post stroke
timeFrame: 90 days
measure: Procedural time
timeFrame: Day 0
measure: Dual anti platelet therapy (DAPT) - Assay values
timeFrame: Day 0
measure: Bleeding events - The Bleeding Academic Research Consortium
timeFrame: 12 months
measure: Re-treatment procedures
timeFrame: 12 months
measure: Incomplete aneurysms occlusion
timeFrame: 12 months
Locations:
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Gold Coast
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: Gold Coast University Hospital
name: Henry (Hal) A Rice MBBS FRANZCR
role: STUDY_DIRECTOR
affiliation: Gold Coast University Hospital
name: Laetitia E de Villiers MBCHB FRANZCR
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital
name: Jason D Wenderoth BSc MBBS (Hons 1) FRANZCR
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Charles Gardiner Hospital
name: Albert Chiu MBBS (Hons.) FRANZCR
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool Hospital
name: Nathan Manning BApSci, BSci(Hons) MBBS FRANZCR CCINR
role: PRINCIPAL_INVESTIGATOR
References: