Evidence map›Paper›PMID 31308197›Full record

Trial reportJournal of neurointerventional surgery2020

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.

Ricardo A Hanel, David F Kallmes, Demetrius Klee Lopes, Peter Kim Nelson, Adnan Siddiqui, Pascal Jabbour, Vitor M Pereira, Istvan Szikora István, Osama O Zaidat, Chetan Bettegowda and 19 more

2 registry-linked trialsAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurointerventional surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 167 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
167citing papers in PubMed, 9 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
NCT06416657 narecruitingnot on this mapstarted 2024, after this paper: background citation

General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial

TypeinterventionalSponsorMing LvRan2024 to 2026Enrolled188ConditionsIntracranial AneurysmArmsDifferent anesthesia methods, namely local anesthesia and general anesthesia
3 · Its place in the literature

Who cites it

167 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  2. The safety profile of single antiplatelet therapy with flow diverters: Systematic review and meta-analysis.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
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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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107 more citing papers are in PubMed but not listed here.

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

29 authors.

Ricardo A HanelBaptist Neurological Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
David F KallmesDepartments of Neurosurgery and Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Demetrius Klee LopesBrain and Spine Institute, Advocate Aurora Health, Chicago, Illinois, USA.
Peter Kim NelsonInterventional Radiology, New York University Langone Medical Center, New York, New York, USA.
Adnan SiddiquiDepartments of Neurosurgery and Radiology, 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.
Vitor M PereiraDepartments of Medical Imaging and Surgery, Division of Neuroradiology and Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.
Istvan Szikora IstvánDepartment of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary.
Osama O ZaidatNeuroscience Institute, St Vincent Mercy Hospital, Toledo, Ohio, USA.ORCID http://orcid.org/0000-0003-4881-4698
Chetan BettegowdaDepartment of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Geoffrey P ColbyDepartment of Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.ORCID http://orcid.org/0000-0002-3376-0933
Maxim MokinDepartment of Neurosurgery, University of South Florida, Tampa, Florida, USA.ORCID http://orcid.org/0000-0003-4270-8667
Clemens SchirmerDepartment of Neurological Surgery, Geisinger Clinic, Danville, Pennsylvania, USA.
Frank R HellingerDepartment of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA.
Curtis Given IiDepartment 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, 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.
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.
David FiorellaDepartment of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA.ORCID http://orcid.org/0000-0002-2677-8780
Don FreiDepartment of Neuroradiology, Swedish Medical Center, Denver, Colorado, USA.
Beverly Aagaard-KienitzDepartment of Neurological Surgery, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
Orlando DiazDivision of Interventional Neuroradiology, Houston Methodist Research Institute, Houston, Texas, USA.
Adel M MalekDepartment of Neurosurgery, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.
C Michael CawleyDepartments of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.
Ajit S PuriNew England Center for Stroke Research, Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.

objectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.

methodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.

resultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).

conclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.

trial registrationNCT02186561.

Indexed as

AdultAgedBlood Vessel ProsthesisEmbolization, TherapeuticFemaleFollow-Up StudiesHumansIntracranial AneurysmMaleMiddle AgedProspective StudiesRetreatmentSelf Expandable Metallic StentsTreatment Outcomeaneurysmarterybrainflow diverterintervention

Identifiers

PMID31308197
PMCPMC6996098

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.