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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
Date last updated
11/01/2022

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
This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.
Trial website
https://clinicaltrials.gov/study/NCT02719522
Trial related presentations / publications
Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I, Fiorella D. The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol. 2011 Jan;32(1):34-40. doi: 10.3174/ajnr.A2421. Epub 2010 Dec 9.
Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013 Jun;267(3):858-68. doi: 10.1148/radiol.13120099. Epub 2013 Feb 15.
Kallmes DF, Hanel R, Lopes D, Boccardi E, Bonafe A, Cekirge S, Fiorella D, Jabbour P, Levy E, McDougall C, Siddiqui A, Szikora I, Woo H, Albuquerque F, Bozorgchami H, Dashti SR, Delgado Almandoz JE, Kelly ME, Turner R 4th, Woodward BK, Brinjikji W, Lanzino G, Lylyk P. International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study. AJNR Am J Neuroradiol. 2015 Jan;36(1):108-15. doi: 10.3174/ajnr.A4111. Epub 2014 Oct 29. Erratum In: AJNR Am J Neuroradiol. 2015 May;36(5):E39-40. doi: 10.3174/ajnr.A4307.
Chitale R, Gonzalez LF, Randazzo C, Dumont AS, Tjoumakaris S, Rosenwasser R, Chalouhi N, Gordon D, Jabbour P. Single center experience with pipeline stent: feasibility, technique, and complications. Neurosurgery. 2012 Sep;71(3):679-91; discussion 691. doi: 10.1227/NEU.0b013e318260fe86.
Saatci I, Yavuz K, Ozer C, Geyik S, Cekirge HS. Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow-up results. AJNR Am J Neuroradiol. 2012 Sep;33(8):1436-46. doi: 10.3174/ajnr.A3246. Epub 2012 Jul 19.
Kan P, Siddiqui AH, Veznedaroglu E, Liebman KM, Binning MJ, Dumont TM, Ogilvy CS, Gaughen JR Jr, Mocco J, Velat GJ, Ringer AJ, Welch BG, Horowitz MB, Snyder KV, Hopkins LN, Levy EI. Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device: a U.S. multicenter experience. Neurosurgery. 2012 Dec;71(6):1080-7; discussion 1087-8. doi: 10.1227/NEU.0b013e31827060d9.
Yu SC, Kwok CK, Cheng PW, Chan KY, Lau SS, Lui WM, Leung KM, Lee R, Cheng HK, Cheung YL, Chan CM, Wong GK, Hui JW, Wong YC, Tan CB, Poon WL, Pang KY, Wong AK, Fung KH. Intracranial aneurysms: midterm outcome of pipeline embolization device--a prospective study in 143 patients with 178 aneurysms. Radiology. 2012 Dec;265(3):893-901. doi: 10.1148/radiol.12120422. Epub 2012 Sep 20.
McAuliffe W, Wycoco V, Rice H, Phatouros C, Singh TJ, Wenderoth J. Immediate and midterm results following treatment of unruptured intracranial aneurysms with the pipeline embolization device. AJNR Am J Neuroradiol. 2012 Jan;33(1):164-70. doi: 10.3174/ajnr.A2727. Epub 2011 Oct 6.
Skukalek SL, Winkler AM, Kang J, Dion JE, Cawley CM, Webb A, Dannenbaum MJ, Schuette AJ, Asbury B, Tong FC. Effect of antiplatelet therapy and platelet function testing on hemorrhagic and thrombotic complications in patients with cerebral aneurysms treated with the pipeline embolization device: a review and meta-analysis. J Neurointerv Surg. 2016 Jan;8(1):58-65. doi: 10.1136/neurintsurg-2014-011145. Epub 2014 Nov 10.
Rice H, Martinez Galdamez M, Holtmannspotter M, Spelle L, Lagios K, Ruggiero M, Vega P, Sonwalkar H, Chapot R, Lamin S. Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study. J Neurointerv Surg. 2020 Nov;12(11):1107-1112. doi: 10.1136/neurintsurg-2020-015943. Epub 2020 Jun 1.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02719522