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

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.

Conditions

• Intracranial Aneurysm
• Cerebral Aneurysm
• Subarachnoid Hemorrhage
• Stroke, Acute
• Cerebral Hemorrhage
• Cerebral Stroke
• Neurologic Disorder

Interventions

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.

Sponsors & Collaborators

• Prince of Wales Hospital, Sydney

  collaborator OTHER_GOV

• Liverpool Hospital, Sydney

  collaborator UNKNOWN

• Sir Charles Gairdner Hospital

  collaborator OTHER

• Gold Coast Hospital and Health Service

  lead OTHER_GOV

Principal Investigators

• Henry (Hal) A Rice MBBS FRANZCR · Gold Coast University Hospital

• Laetitia E de Villiers MBCHB FRANZCR · Gold Coast University Hospital

• Jason D Wenderoth BSc MBBS (Hons 1) FRANZCR · Prince of Wales Hospital

• Albert Chiu MBBS (Hons.) FRANZCR · Sir Charles Gardiner Hospital

• Nathan Manning BApSci, BSci(Hons) MBBS FRANZCR CCINR · Liverpool Hospital

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-30

Primary Completion

2020-01-30

Completion

2020-09-30

FDA Device

Yes

Countries

• Australia

Study Locations