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

Stroke, Acute Clinical Trial

— SCOPE-AUS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03815149
• Other study ID #: GCMR0002
• Secondary ID: ISR-2017-10909
• Status: Recruiting
• Start date: May 30, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2019
• Source: Gold Coast Hospital and Health Service
• Contact: Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC
• Phone: +61 7 5687 6447
• Email: maame.owusu[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Cerebral Hemorrhage
• Cerebral Stroke
• Hemorrhage
• Intracranial Aneurysm
• Nervous System Diseases
• Neurologic Disorder
• Stroke
• Stroke, Acute
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
Australia	Gold Coast University Hospital	Gold Coast	Queensland
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
Gold Coast Hospital and Health Service	Liverpool Hospital, Sydney, Prince of Wales Hospital, Sydney, Sir Charles Gairdner Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional outcomes - Modified Rankin Scale, nil disability	Change in mRS from baseline mRS 0-1; mRS is a clinician-reported measure of global disability. Level 0 indicates no disability (better outcome, maximum score). Level 6 indicates death (worst outcome, minimum score).	90 days
Other	Functional outcomes - Modified Rankin Scale, disability	Change in mRS from baseline mRS 3-6; mRS is a clinician-reported measure of global disability. Level 0 indicates no disability (better outcome, maximum score). Level 5 indicates severe disability, bedridden, incontinent and requiring nursing care and attention (poor outcome, low score). Level 6 indicates death (worst outcome, minimum score).	90 days
Other	Functional outcomes - number of days spent in hospital	mean time in hospital, an intensive care unit, or rehabilitation facility	90 days
Other	Functional outcomes - home time post stroke	Number of days spent at home after a post-operative stroke	90 days
Other	Procedural time	Time from start to end of the procedure	Day 0
Other	Dual anti platelet therapy (DAPT) - Assay values	% inhibition - DAPT assay values demonstrating impaired platelet activity	Day 0
Other	Bleeding events - The Bleeding Academic Research Consortium	Proportion, severity and classification of bleeding events	12 months
Other	Re-treatment procedures	Proportion of aneurysms requiring re-treatment procedures	12 months
Other	Incomplete aneurysms occlusion	Proportion of aneurysms with incomplete occlusion	12 months
Primary	Prevalence of stroke (short-term)	Prevalence and severity of ischaemic and haemorrhagic stroke post procedure	30 days
Primary	Mortality due to stroke (short-term)	Number of deaths due to ischaemic and haemorrhagic post procedure	30 days
Primary	Morbidity due to neurological adverse events of interest (short-term)	Prevalence of neurological adverse events of interest post procedure	30 days
Primary	Prevalence of stroke (long-term)	Prevalence and severity of ischaemic and haemorrhagic stroke post procedure	12 months
Primary	Morbidity due to neurological adverse events of interest (long-term)	Prevalence of neurological adverse events of interest post procedure	12 months
Primary	Mortality due to stroke (long-term)	Number of deaths due to ischaemic and haemorrhagic post procedure	12 months
Primary	Mortality due to neurological adverse events of interest (long-term)	Deaths due to other neurological adverse events of interest	12 months
Primary	All cause mortality	Deaths due to any cause	12 months
Secondary	Aneurysm occlusion - Wall apposition	Proportion of aneurysms with good wall apposition at post-operative time point	Day 0
Secondary	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)	6 months
Secondary	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)	12 months
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	30 days
Secondary	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).	90 days
Secondary	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).	6 months
Secondary	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).	12 months