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

Last updated: December 9, 2019
Sponsor: Gold Coast Hospital and Health Service
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Aneurysm

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT03815149
GCMR0002
ISR-2017-10909
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years of age

  • Medical records from patients that have received a Pipeline™ Flex Embolization Devicewith Shield Technology™ inclusive of all indications such as an elective procedure,unscheduled procedure or emergency procedure for an unruptured or rupturedintracranial aneurysm(s) at each study site

  • Medical records from patients that have received other neurovascular therapies such ascoils, intracranial stents etc. with a Pipeline™ Flex Embolization Device with ShieldTechnology™ used as an adjunctive device during the index procedure

Exclusion

Exclusion Criteria:

  • Medical records from patients that have not received a Pipeline™ Flex EmbolizationDevice with Shield Technology™ to treat an intracranial aneurysm

Study Design

Total Participants: 500
Study Start date:
May 30, 2019
Estimated Completion Date:
September 30, 2020

Study 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.

Connect with a study center

  • Liverpool Hospital

    Sydney, New South Wales 2170
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Sydney, New South Wales 2000
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Gold Coast, Queensland 4215
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Perth, Western Australia 6009
    Australia

    Site Not Available

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