Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy

NCT02719522 | Completed Results

• 1 other identifier: NV-PED-10
• Study Type: observational
• Target: 205
• Locations: 11 countries
• Sites: 21

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• Safety - Stroke/Death Occurrence

  Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year)

  1 year

• Effectiveness - Aneurysm Occlusion

  Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year)

  1 year

Secondary Outcomes (3)

• Safety - Stroke/Death Occurrence - 30 Days

  30 days

• Safety - Intracerebral Hemorrhage (ICH)

  1 year

• Effectiveness - Deployment Rate

  1 year

Interventions

Pipeline™ Flex Embolization Device with Shield Technology™ DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have an intracranial aneurysm (IA). The Pipeline™ Flex Embolization Device with Shield Technology™ will be used according to its Instructions for Use and its intended use during the treatment regimen.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (21)

Gold Coast University Hospital

Southport, QLD 4215, Australia

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Turun Yliopistollinen keskussairaala

Turku, Finland

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Charité Centrum

Berlin, Germany

Location

Alfried Krupp Krankenhaus

Essen, Germany

Location

Universitätsklinikums Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Germany

Location

Hellenic Airforce Hospital

Athens, Greece

Location

Országos Klinikai Idegtudományi Intézet

Budapest, Hungary

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

Ospedale M. Bufalini

Cesena, Italy

Location

Istituto Neurologico Carlo Besta

Milan, Italy

Location

Hospital Universitario Cruces

Barakaldo, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario de la Princesa

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Royal Preston Hospital

Preston, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 21148256 BACKGROUND

• 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.

  PMID: 23418004 BACKGROUND

• 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.

  PMID: 25355814 BACKGROUND

• 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.

  PMID: 22653389 BACKGROUND

• 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.

  PMID: 22821921 BACKGROUND

• 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.

  PMID: 22948199 BACKGROUND

• 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.

  PMID: 22996749 BACKGROUND

• 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.

  PMID: 21979492 BACKGROUND

• 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.

  PMID: 25385746 BACKGROUND

• 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.

  PMID: 32482834 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Claudia Campo
• Organization: Medtronic Neurovascular

claudia.campo@medtronic.com

0039 0224137325

Study Officials

• Saleh Lamin

  The Queen Elizabeth Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 25, 2016
• Study Start: March 1, 2016
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: January 11, 2022
• Results First Posted: July 8, 2020

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); GR (1); FR (1); IL (1); DK (1); GB (2); HU (1); DE (5); IT (2); AU (1); FI (1)