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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03815149
Registration number
NCT03815149
Ethics application status
Date submitted
6/10/2018
Date registered
24/01/2019
Date last updated
10/12/2019
Titles & IDs
Public title
Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
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Scientific 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)
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Secondary ID [1]
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ISR-2017-10909
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Secondary ID [2]
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GCMR0002
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Universal Trial Number (UTN)
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Trial acronym
SCOPE-AUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysm
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Cerebral Aneurysm
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Subarachnoid Hemorrhage
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Stroke, Acute
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Cerebral Hemorrhage
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Cerebral Stroke
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Neurologic Disorder
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Pipeline™ Flex Embolization Device with Shield Technology™
patients with intracranial aneurysm(s) - Standard of care elective, unscheduled or emergency procedures for the treatment of an unruptured or ruptured intracranial aneurysm(s) using a Pipeline™ Flex Embolization Device(s) with Shield Technology™
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of stroke (short-term)
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Assessment method [1]
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Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
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Timepoint [1]
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30 days
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Primary outcome [2]
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Mortality due to stroke (short-term)
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Assessment method [2]
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Number of deaths due to ischaemic and haemorrhagic post procedure
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Timepoint [2]
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30 days
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Primary outcome [3]
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Morbidity due to neurological adverse events of interest (short-term)
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Assessment method [3]
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Prevalence of neurological adverse events of interest post procedure
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Timepoint [3]
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30 days
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Primary outcome [4]
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Prevalence of stroke (long-term)
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Assessment method [4]
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Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
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Timepoint [4]
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12 months
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Primary outcome [5]
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Morbidity due to neurological adverse events of interest (long-term)
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Assessment method [5]
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Prevalence of neurological adverse events of interest post procedure
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Timepoint [5]
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12 months
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Primary outcome [6]
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Mortality due to stroke (long-term)
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Assessment method [6]
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Number of deaths due to ischaemic and haemorrhagic post procedure
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Timepoint [6]
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12 months
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Primary outcome [7]
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Mortality due to neurological adverse events of interest (long-term)
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Assessment method [7]
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Deaths due to other neurological adverse events of interest
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Timepoint [7]
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12 months
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Primary outcome [8]
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All cause mortality
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Assessment method [8]
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Deaths due to any cause
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Timepoint [8]
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12 months
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Secondary outcome [1]
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Aneurysm occlusion - Wall apposition
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Assessment method [1]
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Proportion of aneurysms with good wall apposition at post-operative time point
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Timepoint [1]
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Day 0
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Secondary outcome [2]
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Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)
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Assessment method [2]
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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)
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)
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Assessment method [3]
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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)
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)
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Assessment method [4]
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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).
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Timepoint [4]
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6 months
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Secondary outcome [5]
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Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)
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Assessment method [5]
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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).
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term)
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Assessment method [6]
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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).
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term)
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Assessment method [7]
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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).
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Aneurysm occlusion - In-stent stenosis (ISS; short-term)
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Assessment method [8]
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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).
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Timepoint [8]
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30 days
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Secondary outcome [9]
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Aneurysm occlusion - In-stent stenosis (ISS; short-term)
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Assessment method [9]
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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).
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Timepoint [9]
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90 days
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Secondary outcome [10]
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Aneurysm occlusion - In-stent stenosis (ISS; long-term)
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Assessment method [10]
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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).
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Timepoint [10]
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6 months
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Secondary outcome [11]
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Aneurysm occlusion - In-stent stenosis (ISS; long-term)
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Assessment method [11]
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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).
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Timepoint [11]
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12 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Medical records from patients that have not received a Pipeline™ Flex Embolization
Device with Shield Technology™ to treat an intracranial aneurysm
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/05/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2020
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Prince of Wales Hospital - Sydney
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Recruitment hospital [2]
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Liverpool Hospital - Sydney
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Recruitment hospital [3]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [4]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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2170 - Sydney
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Recruitment postcode(s) [3]
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4215 - Gold Coast
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Recruitment postcode(s) [4]
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6009 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Gold Coast Hospital and Health Service
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Prince of Wales Hospital, Sydney
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Liverpool Hospital, Sydney
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Sir Charles Gairdner Hospital
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03815149
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Henry (Hal) A Rice MBBS FRANZCR
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Address
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Gold Coast University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC
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Address
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Country
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Phone
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+61 7 5687 6447
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03815149
Download to PDF