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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03815149




Registration number
NCT03815149
Ethics application status
Date submitted
6/10/2018
Date registered
24/01/2019
Date last updated
24/01/2019

Titles & IDs
Public title
Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
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)
Secondary ID [1] 0 0
ISR-2017-10909
Secondary ID [2] 0 0
GCMR0002
Universal Trial Number (UTN)
Trial acronym
SCOPE-AUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysm 0 0
Cerebral Aneurysm 0 0
Subarachnoid Hemorrhage 0 0
Stroke, Acute 0 0
Cerebral Hemorrhage 0 0
Cerebral Stroke 0 0
Neurologic Disorder 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of stroke (short-term) - Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Mortality due to stroke (short-term) - Number of deaths due to ischaemic and haemorrhagic post procedure
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Morbidity due to neurological adverse events of interest (short-term) - Prevalence of neurological adverse events of interest post procedure
Timepoint [3] 0 0
30 days
Primary outcome [4] 0 0
Prevalence of stroke (long-term) - Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
Morbidity due to neurological adverse events of interest (long-term) - Prevalence of neurological adverse events of interest post procedure
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
Mortality due to stroke (long-term) - Number of deaths due to ischaemic and haemorrhagic post procedure
Timepoint [6] 0 0
12 months
Primary outcome [7] 0 0
Mortality due to neurological adverse events of interest (long-term) - Deaths due to other neurological adverse events of interest
Timepoint [7] 0 0
12 months
Primary outcome [8] 0 0
All cause mortality - Deaths due to any cause
Timepoint [8] 0 0
12 months
Secondary outcome [1] 0 0
Aneurysm occlusion - Wall apposition - Proportion of aneurysms with good wall apposition at post-operative time point
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 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)
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
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).
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
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).
Timepoint [9] 0 0
90 days
Secondary outcome [10] 0 0
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).
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
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).
Timepoint [11] 0 0
12 months

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
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Medical records from patients that have not received a Pipeline™ Flex Embolization
Device with Shield Technology™ to treat an intracranial aneurysm

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [2] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
4215 - Gold Coast
Recruitment postcode(s) [4] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Gold Coast Hospital and Health Service
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Prince of Wales Hospital, Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Liverpool Hospital, Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sir Charles Gairdner Hospital
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03815149
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry (Hal) A Rice MBBS FRANZCR
Address 0 0
Gold Coast University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC
Address 0 0
Country 0 0
Phone 0 0
+61 7 5687 6447
Fax 0 0
Email 0 0
maame.owusu@health.qld.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03815149