Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
SCOPE-AUS
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)
2 other identifiers
observational
500
1 country
4
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2019
CompletedStudy Start
First participant enrolled
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedDecember 10, 2019
December 1, 2019
8 months
October 6, 2018
December 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Prevalence of stroke (short-term)
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
30 days
Mortality due to stroke (short-term)
Number of deaths due to ischaemic and haemorrhagic post procedure
30 days
Morbidity due to neurological adverse events of interest (short-term)
Prevalence of neurological adverse events of interest post procedure
30 days
Prevalence of stroke (long-term)
Prevalence and severity of ischaemic and haemorrhagic stroke post procedure
12 months
Morbidity due to neurological adverse events of interest (long-term)
Prevalence of neurological adverse events of interest post procedure
12 months
Mortality due to stroke (long-term)
Number of deaths due to ischaemic and haemorrhagic post procedure
12 months
Mortality due to neurological adverse events of interest (long-term)
Deaths due to other neurological adverse events of interest
12 months
All cause mortality
Deaths due to any cause
12 months
Secondary Outcomes (11)
Aneurysm occlusion - Wall apposition
Day 0
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term)
6 months
Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term)
12 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term)
6 months
Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term)
12 months
- +6 more secondary outcomes
Other Outcomes (9)
Functional outcomes - Modified Rankin Scale, nil disability
90 days
Functional outcomes - Modified Rankin Scale, disability
90 days
Functional outcomes - number of days spent in hospital
90 days
- +6 more other outcomes
Study Arms (1)
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™
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Medical records from patients that have not received a Pipeline™ Flex Embolization Device with Shield Technology™ to treat an intracranial aneurysm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gold Coast Hospital and Health Servicelead
- Prince of Wales Hospital, Sydneycollaborator
- Liverpool Hospital, Sydneycollaborator
- Sir Charles Gairdner Hospitalcollaborator
Study Sites (4)
Prince of Wales Hospital
Sydney, New South Wales, 2000, Australia
Liverpool Hospital
Sydney, New South Wales, 2170, Australia
Gold Coast University Hospital
Gold Coast, Queensland, 4215, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henry (Hal) A Rice MBBS FRANZCR
Gold Coast University Hospital
- PRINCIPAL INVESTIGATOR
Laetitia E de Villiers MBCHB FRANZCR
Gold Coast University Hospital
- PRINCIPAL INVESTIGATOR
Jason D Wenderoth BSc MBBS (Hons 1) FRANZCR
Prince of Wales Hospital
- PRINCIPAL INVESTIGATOR
Albert Chiu MBBS (Hons.) FRANZCR
Sir Charles Gardiner Hospital
- PRINCIPAL INVESTIGATOR
Nathan Manning BApSci, BSci(Hons) MBBS FRANZCR CCINR
Liverpool Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2018
First Posted
January 24, 2019
Study Start
May 30, 2019
Primary Completion
January 30, 2020
Study Completion
September 30, 2020
Last Updated
December 10, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- To align with national recommendations for data sharing, the SCOPE-AUS metadata (description of the data) shall be published in a metadata record through Research Data Australia Registry, an entity of the Australian National Data Service. The goal is to ensure that data that is unique to the discipline of Interventional Neuroradiology is available for reuse in future research purposes. The SCOPE-AUS metadata will be available at 12 months following primary publication until 48 months.
- Access Criteria
- Access shall be conditional; re-users must be genuine researchers whose proposed use of the data has been approved by an Ethics committee. Re-users are required to cite the SCOPE-AUS dataset in any scholarly outputs. This proposed strategy will uphold Australian privacy laws. The Sponsor/Coordinating Principal Investigator/SCOPE-AUS research team will ultimately retain oversight of all future uses of the data.
This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.