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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02719522




Registration number
NCT02719522
Ethics application status
Date submitted
24/02/2016
Date registered
25/03/2016

Titles & IDs
Public title
Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy
Scientific title
Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)
Secondary ID [1] 0 0
NV-PED-10
Universal Trial Number (UTN)
Trial acronym
SHIELD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Pipeline™ Flex Embolization Device with Shield Technology™

Treatment: Devices: Pipeline™ Flex Embolization Device with Shield Technology™
Pipeline™ Flex Embolization Device with Shield Technology™ utilizes a phosphorylcholine (PC) surface treatment to the implant combined with the PFED delivery system. The Shield Technology™ surface treatment applied to the implant is an inert polymer material created to mimic the outer membrane of a human red blood cell.

The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms and is designed to be placed across the opening (or 'neck') of a brain aneurysm and redirect blood flow away from the aneurysm, causing the blood within the aneurysm to clot.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - Stroke/Death Occurrence
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Effectiveness - Aneurysm Occlusion
Timepoint [2] 0 0
1 year
Secondary outcome [1] 0 0
Safety - Stroke/Death Occurrence - 30 Days
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Safety - Intracerebral Hemorrhage (ICH)
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Effectiveness - Deployment Rate
Timepoint [3] 0 0
1 year

Eligibility
Key inclusion criteria
* Subject has provided written Data Release Form (DRF) or informed consent using the Institutional Review Board (IRB)/ Ethic Committee (EC)-approved consent form and agrees to comply with protocol requirements.
* At least 18 years of age.
* Subject has already been selected for flow diversion therapy as the appropriate treatment.
* Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Major surgery including endovascular procedures within the past 30 days.
* Subject with target IA located in the basilar artery
* Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
* Stent is in place in the parent artery at the target IA location.
* Subject with an acutely (within 30 days) ruptured aneurysm with a Hunt and Hess grade of 4 or higher.
* Any known contraindication to treatment with the Pipeline™ Flex Embolization Device with Shield Technology™ per Instructions for Use.
* The investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.
* Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic.
* Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2019
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
QLD 4215 - Southport
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
Finland
State/province [2] 0 0
Turku
Country [3] 0 0
France
State/province [3] 0 0
Le Kremlin-Bicêtre
Country [4] 0 0
Germany
State/province [4] 0 0
Augsburg
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Germany
State/province [6] 0 0
Essen
Country [7] 0 0
Germany
State/province [7] 0 0
Heidelberg
Country [8] 0 0
Germany
State/province [8] 0 0
Homburg
Country [9] 0 0
Greece
State/province [9] 0 0
Athens
Country [10] 0 0
Hungary
State/province [10] 0 0
Budapest
Country [11] 0 0
Israel
State/province [11] 0 0
Jerusalem
Country [12] 0 0
Italy
State/province [12] 0 0
Cesena
Country [13] 0 0
Italy
State/province [13] 0 0
Milan
Country [14] 0 0
Spain
State/province [14] 0 0
Barakaldo
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Oviedo
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Birmingham
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Neurovascular Clinical Affairs
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic Bakken Research Center
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Saleh Lamin
Address 0 0
The Queen Elizabeth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be available


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02719522