Evidence map›Paper›PMID 35292570›Full record

Trial reportJournal of neurointerventional surgery2023

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

Ricardo A Hanel, Gustavo M Cortez, Demetrius Klee Lopes, Peter Kim Nelson, Adnan H Siddiqui, Pascal Jabbour, Vitor Mendes Pereira, Istvan Szikora István, Osama O Zaidat, Chetan Bettegowda and 20 more

3 registry-linked trialsAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurointerventional surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 49 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02186561 nacompletednot on this map

Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)

TypeinterventionalSponsorMedtronic Neurovascular Clinical AffairsRan2014 to 2018Enrolled197ConditionsIntracranial AneurysmArmsPipeline™ Embolization Device/ Pipeline™Flex Embolization Device
NCT06308952 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation: Protocol of a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

TypeinterventionalSponsorDuan ChuanzhiRan2024 to 2027Enrolled354ConditionsCerebrovascular Event, Stent Stenosis, Ischemic Stroke, Hemorrhagic StrokeArmsAtorvastatin 20mg
NCT06715930 active not recruitingnot on this map

Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients With Intracranial Aneurysm: a Multicenter, Retrospective Model Development and Validation Study

TypeobservationalSponsorBeijing Tiantan HospitalRan2016 to 2025Enrolled1,500ConditionsIntracranial AneurysmArmsInterventional treatment
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  6. Safety and efficacy profile of off-label use of the Pipeline Embolization Device: A systematic review and meta-analysis.Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Ricardo A HanelLyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.ORCID http://orcid.org/0000-0001-7195-5806
Gustavo M CortezLyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
Demetrius Klee LopesBrain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA.ORCID http://orcid.org/0000-0002-6280-0113
Peter Kim NelsonInterventional Radiology, NYU Langone Medical Center, New York, New York, USA.
Adnan H SiddiquiDepartment of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
Pascal JabbourDepartment of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.ORCID http://orcid.org/0000-0002-1544-4910
Vitor Mendes PereiraDivision of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-6804-3985
Istvan Szikora IstvánDepartment of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary.
Osama O ZaidatNeuroscience Institute, Mercy Health Saint Vincent Medical Center, Toledo, Ohio, USA.
Chetan BettegowdaDepartment of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Geoffrey P ColbyDepartment Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.
Maxim MokinDepartment of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.ORCID http://orcid.org/0000-0003-4270-8667
Clemens M SchirmerDepartment of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA.
Frank R HellingerDepartment of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA.
Curtis GivenDepartment of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
Timo KringsDepartment of Medical Imaging, Toronto Western Hospital, Toronto, Ontario, Canada.
Philipp TausskyDepartment of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA.ORCID http://orcid.org/0000-0001-9247-0146
Gabor TothCerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.ORCID http://orcid.org/0000-0002-3646-3635
Justin F FraserDepartment of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.ORCID http://orcid.org/0000-0002-5980-3989
Michael ChenDepartment of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA.ORCID http://orcid.org/0000-0003-2412-8167
Ryan PriestCharles T Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon, USA.
Peter KanDepartment of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.ORCID http://orcid.org/0000-0001-6649-4128
David FiorellaDepartment of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA.ORCID http://orcid.org/0000-0002-2677-8780
Donald FreiDepartment of Neuroradiology, Swedish Medical Center, Englewood, Colorado, USA.ORCID http://orcid.org/0000-0002-7811-5030
Beverly Aagaard-KienitzDepartment of Neurological Surgery, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
Orlando DiazCerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA.
Adel M MalekDepartment of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.ORCID http://orcid.org/0000-0002-0642-7609
C Michael CawleyDepartment of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.
Ajit S PuriDepartment of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
David F KallmesDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.

methodsPREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.

resultsAs per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.

conclusionsThe PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.

trial registrationNCT02186561.

Indexed as

Embolization, TherapeuticIntracranial AneurysmCerebral AngiographyFollow-Up StudiesHumansProspective StudiesRetrospective StudiesTreatment Outcomeaneurysmflow diverterintervention

Identifiers

PMID35292570
PMCPMC9985759

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.