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Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms (SCOPE-AUS)

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ClinicalTrials.gov Identifier: NCT03815149
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborators:
Prince of Wales Hospital, Sydney
Liverpool Hospital, Sydney
Sir Charles Gairdner Hospital
Information provided by (Responsible Party):
Gold Coast Hospital and Health Service

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.


Condition or disease Intervention/treatment
Intracranial Aneurysm Cerebral Aneurysm Subarachnoid Hemorrhage Stroke, Acute Cerebral Hemorrhage Cerebral Stroke Neurologic Disorder Device: Pipeline™ Flex Embolization Device with Shield Technology™

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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™
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.
Other Name: Neurointerventional procedure




Primary Outcome Measures :
  1. Prevalence of stroke (short-term) [ Time Frame: 30 days ]
    Prevalence and severity of ischaemic and haemorrhagic stroke post procedure

  2. Mortality due to stroke (short-term) [ Time Frame: 30 days ]
    Number of deaths due to ischaemic and haemorrhagic post procedure

  3. Morbidity due to neurological adverse events of interest (short-term) [ Time Frame: 30 days ]
    Prevalence of neurological adverse events of interest post procedure

  4. Prevalence of stroke (long-term) [ Time Frame: 12 months ]
    Prevalence and severity of ischaemic and haemorrhagic stroke post procedure

  5. Morbidity due to neurological adverse events of interest (long-term) [ Time Frame: 12 months ]
    Prevalence of neurological adverse events of interest post procedure

  6. Mortality due to stroke (long-term) [ Time Frame: 12 months ]
    Number of deaths due to ischaemic and haemorrhagic post procedure

  7. Mortality due to neurological adverse events of interest (long-term) [ Time Frame: 12 months ]
    Deaths due to other neurological adverse events of interest

  8. All cause mortality [ Time Frame: 12 months ]
    Deaths due to any cause


Secondary Outcome Measures :
  1. Aneurysm occlusion - Wall apposition [ Time Frame: Day 0 ]
    Proportion of aneurysms with good wall apposition at post-operative time point

  2. Aneurysm occlusion - Consensus grading scale for endovascular occlusion (short-term) [ Time Frame: 6 months ]
    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)

  3. Aneurysm occlusion - Consensus grading scale for endovascular occlusion (long-term) [ Time Frame: 12 months ]
    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)

  4. Aneurysm occlusion - O'Kelly Marotta Scale (OKM; short-term) [ Time Frame: 6 months ]
    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).

  5. Aneurysm occlusion - O'Kelly Marotta Scale (OKM; long-term) [ Time Frame: 12 months ]
    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).

  6. Aneurysm occlusion - Modified Raymond Roy Classification (MRRC; short-term) [ Time Frame: 6 months ]
    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).

  7. Aneurysm occlusion - Modified Raymond Ray Classification (MRRC; long-term) [ Time Frame: 12 months ]
    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).

  8. Aneurysm occlusion - In-stent stenosis (ISS; short-term) [ Time Frame: 30 days ]
    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).

  9. Aneurysm occlusion - In-stent stenosis (ISS; short-term) [ Time Frame: 90 days ]
    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).

  10. Aneurysm occlusion - In-stent stenosis (ISS; long-term) [ Time Frame: 6 months ]
    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).

  11. Aneurysm occlusion - In-stent stenosis (ISS; long-term) [ Time Frame: 12 months ]
    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).


Other Outcome Measures:
  1. Functional outcomes - Modified Rankin Scale, nil disability [ Time Frame: 90 days ]
    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).

  2. Functional outcomes - Modified Rankin Scale, disability [ Time Frame: 90 days ]
    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).

  3. Functional outcomes - number of days spent in hospital [ Time Frame: 90 days ]
    mean time in hospital, an intensive care unit, or rehabilitation facility

  4. Functional outcomes - home time post stroke [ Time Frame: 90 days ]
    Number of days spent at home after a post-operative stroke

  5. Procedural time [ Time Frame: Day 0 ]
    Time from start to end of the procedure

  6. Dual anti platelet therapy (DAPT) - Assay values [ Time Frame: Day 0 ]
    % inhibition - DAPT assay values demonstrating impaired platelet activity

  7. Bleeding events - The Bleeding Academic Research Consortium [ Time Frame: 12 months ]
    Proportion, severity and classification of bleeding events

  8. Re-treatment procedures [ Time Frame: 12 months ]
    Proportion of aneurysms requiring re-treatment procedures

  9. Incomplete aneurysms occlusion [ Time Frame: 12 months ]
    Proportion of aneurysms with incomplete occlusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815149


Contacts
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Contact: Maame Amma P Owusu RN, BSc, MNurSt, NVRN-BC +61 7 5687 6447 maame.owusu@health.qld.gov.au
Contact: Henry (Hal) A Rice MBBS FRANZ +61 7 5687 4430 hal.rice@health.qld.gov.au

Locations
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Australia, New South Wales
Prince of Wales Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2000
Contact: Jason D Wenderoth MBBS(Hons 1) FRANZCR         
Sub-Investigator: Andrew Cheung BSc MBBS(Hons 1) FRANZCR         
Sub-Investigator: Nathan Manning BApSci, BSci(Hons), MBBS, FRANZCR CCINR         
Liverpool Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2170
Contact: Nathan Manning BApSci, BSci(Hons), MBBS, FRANZCR, CCINR FRANZCR         
Sub-Investigator: Jason Wenderoth MBBS (Hons 1), FRANZCR         
Sub-Investigator: Andrew Cheung BSc(Med), MBBS (Hons 1), FRANZCR         
Australia, Queensland
Gold Coast University Hospital Recruiting
Gold Coast, Queensland, Australia, 4215
Contact: Henry (Hal) A Rice MBBS FRANZCR         
Contact: Maame Amma P Owusu RN BSc MNurst NVRN-BC    +61 7 5687 6447    maame.owusu@health.qld.gov.au   
Principal Investigator: Henry (Hal) A Rice MBBS FRANZCR         
Principal Investigator: Laetitia E de Villiers MBCHB FRANZCR         
Australia, Western Australia
Sir Charles Gairdner Hospital Not yet recruiting
Perth, Western Australia, Australia, 6009
Contact: Albert Chiu MBBS (Hons) FRANZCR         
Sub-Investigator: William McAuliffe MBBS FRANZCR         
Sub-Investigator: Timothy Phillips MBBS GDSA FRANZCR CCINR         
Sponsors and Collaborators
Gold Coast Hospital and Health Service
Prince of Wales Hospital, Sydney
Liverpool Hospital, Sydney
Sir Charles Gairdner Hospital
Investigators
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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

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Responsible Party: Gold Coast Hospital and Health Service
ClinicalTrials.gov Identifier: NCT03815149     History of Changes
Other Study ID Numbers: GCMR0002
ISR-2017-10909 ( Other Grant/Funding Number: Medtronic External Research Program )
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://researchdata.ands.org.au/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Gold Coast Hospital and Health Service:
Interventional Neuroradiology
Diagnostic neuroradiology
Neurosurgery
Neurovascular Devices
Flow Diversion Device

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Cerebral Hemorrhage
Brain Diseases
Stroke
Hemorrhage
Subarachnoid Hemorrhage
Nervous System Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Intracranial Arterial Diseases