Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy
NCT ID: NCT02719522
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
205 participants
OBSERVATIONAL
2016-03-31
2019-08-22
Brief Summary
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Detailed Description
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Subjects will undergo standard of care follow-up visits. Data generated per standard of care will be collected for 1 year beyond the index procedure.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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Saleh Lamin
Role: STUDY_CHAIR
The Queen Elizabeth Hospital
Locations
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Gold Coast University Hospital
Southport, , Australia
Rigshospitalet
Copenhagen, , Denmark
Turun Yliopistollinen keskussairaala
Turku, , Finland
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Universitätsklinikum Augsburg
Augsburg, , Germany
Charité Centrum
Berlin, , Germany
Alfried Krupp Krankenhaus
Essen, , Germany
Universitätsklinikums Heidelberg
Heidelberg, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
Hellenic Airforce Hospital
Athens, , Greece
Országos Klinikai Idegtudományi Intézet
Budapest, , Hungary
Hadassah Medical Organization
Jerusalem, , Israel
Ospedale M. Bufalini
Cesena, , Italy
Istituto Neurologico Carlo Besta
Milan, , Italy
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NV-PED-10
Identifier Type: -
Identifier Source: org_study_id
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