Evidence map›Paper›PMID 30262655›Full record

ArticleJournal of neurointerventional surgery2019

Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.

Mario Martínez-Galdámez, Saleh M Lamin, Konstantinos G Lagios, Thomas Liebig, Elisa F Ciceri, Rene Chapot, Luc Stockx, Swarupsinh Chavda, Christoph Kabbasch, Giuseppe Faragò and 4 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Journal of neurointerventional surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02390037 (Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study), which is not on this map. Cited by 57 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 4 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.

NCT02390037 completednot on this map

Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

TypeobservationalSponsorMedtronic Neurovascular Clinical AffairsRan2015 to 2016Enrolled50ConditionsAneurysm
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Pooled it
  5. Trial
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  7. Article
  8. Angiographic and clinical outcomes from 396 aneurysms treated with the pipeline flex embolization device with shield technology.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
    Article
  9. Article
  10. Early clinical experience with the new generation Pipeline Vantage flow diverter in the treatment of unruptured saccular aneurysms using short-term dual antiplatelet therapy.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
    Article
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  14. Flow diverter surface modifications for aneurysm treatment: A review of the mechanisms and data behind existing technologies.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
    Review
  15. First clinical experience with the Derivo 2heal embolization device for the treatment of intracranial aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
    Article
  16. Article
  17. Article
  18. Review
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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

14 authors.

Mario Martínez-GaldámezDepartment of Interventional Neuroradiology/Endovascular Neurosurgery, Fundación Jiménez-Díaz, Madrid, Spain.
Saleh M LaminQueen Elizabeth Hospital Birmingham, Edgbaston, UK.
Konstantinos G LagiosDepartment of Interventional Neuroradiology, Hellenic Air Force Hospital, Goudi, Greece.
Thomas LiebigDepartment of Neuroradiology, Institut für Neuroradiologie, Charite, Berlin, Germany.ORCID http://orcid.org/0000-0001-5640-7780
Elisa F CiceriDepartment of Interventional Neuroradiology, Foundation Neurological Institution 'C Besta', Milan, Italy.
Rene ChapotDepartment of Neuroradiology, Alfried Krupp Krankenhaus, Essen, Germany.
Luc StockxDepartment of Neuroradiology, Ziekenhuizen Oost-Limburg, Genk, Belgium.
Swarupsinh ChavdaQueen Elizabeth Hospital Birmingham, Edgbaston, UK.
Christoph KabbaschDepartment of Neuroradiology, Institut für Neuroradiologie, Charite, Berlin, Germany.
Giuseppe FaragòDepartment of Interventional Neuroradiology, Foundation Neurological Institution 'C Besta', Milan, Italy.ORCID http://orcid.org/0000-0002-7516-3512
Hannes NordmeyerDepartment of Neuroradiology, Alfried Krupp Krankenhaus, Essen, Germany.ORCID http://orcid.org/0000-0002-8049-1203
Thierry BoulangerDepartment of Neuroradiology, Ziekenhuizen Oost-Limburg, Genk, Belgium.
Mariangela PianoDepartment of Neuroradiology, Ospedale Niguarda Ca' Granda, Milan, Italy.
Edoardo P BoccardiDepartment of Neuroradiology, Ospedale Niguarda Ca' Granda, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. MATERIALS AND

methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year.

resultsFifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment.

conclusionsOur 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. TRIAL REGISTRATION NUMBER: NCT02390037.

Indexed as

AdultAgedBlood Vessel ProsthesisCerebral AngiographyEmbolization, TherapeuticFemaleFollow-Up StudiesHumansIntracranial AneurysmMaleMiddle AgedProspective StudiesRecurrenceRetreatmentTime FactorsTreatment Outcomeintracranial aneurysmphosphorylcholinepipeline embolization device

Identifiers

PMID30262655
PMCPMC6582709

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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.