Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
NCT ID: NCT03815149
Last Updated: 2019-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2019-05-30
2020-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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™
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Prince of Wales Hospital, Sydney
OTHER_GOV
Liverpool Hospital, Sydney
UNKNOWN
Sir Charles Gairdner Hospital
OTHER
Gold Coast Hospital and Health Service
OTHER_GOV
Responsible Party
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Principal Investigators
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Henry (Hal) A Rice MBBS FRANZCR
Role: STUDY_DIRECTOR
Gold Coast University Hospital
Laetitia E de Villiers MBCHB FRANZCR
Role: PRINCIPAL_INVESTIGATOR
Gold Coast University Hospital
Jason D Wenderoth BSc MBBS (Hons 1) FRANZCR
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Albert Chiu MBBS (Hons.) FRANZCR
Role: PRINCIPAL_INVESTIGATOR
Sir Charles Gardiner Hospital
Nathan Manning BApSci, BSci(Hons) MBBS FRANZCR CCINR
Role: PRINCIPAL_INVESTIGATOR
Liverpool Hospital
Locations
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Prince of Wales Hospital
Sydney, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Gold Coast University Hospital
Gold Coast, Queensland, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Countries
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Central Contacts
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Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC
Role: CONTACT
Phone: +61 7 5687 6447
Email: [email protected]
Facility Contacts
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Jason D Wenderoth MBBS(Hons 1) FRANZCR
Role: primary
Nathan Manning BApSci, BSci(Hons), MBBS, FRANZCR, CCINR FRANZCR
Role: primary
Henry (Hal) A Rice MBBS FRANZCR
Role: primary
Maame Amma P Owusu RN BSc MNurst NVRN-BC
Role: backup
Albert Chiu MBBS (Hons) FRANZCR
Role: primary
Other Identifiers
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ISR-2017-10909
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GCMR0002
Identifier Type: -
Identifier Source: org_study_id