Evidence map›Paper›PMID 32482834›Full record

Observational studyJournal of neurointerventional surgery2020

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.

Hal Rice, Mario Martínez Galdámez, Markus Holtmannspötter, Laurent Spelle, Konstantinos Lagios, Maria Ruggiero, Pedro Vega, Hemant Sonwalkar, René Chapot, Saleh Lamin

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study 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 trial NCT02719522 (Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 7% of its field
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.

NCT02719522 completednot on this map

Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)

TypeobservationalSponsorMedtronic Neurovascular Clinical AffairsRan2016 to 2019Enrolled205ConditionsIntracranial AneurysmArmsPipeline™ Flex Embolization Device with Shield Technology™
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. 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
  6. Article
  7. 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
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. A Review of Current Flow Diverters.Journal of neuroendovascular therapy · 2024
    Review
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

10 authors at 10 institutions in 8 countries.

Hal RiceInterventional Neuroradiology, Gold Coast University Hospital, Southport, Queensland, Australia Hal.Rice@qscan.com.au.
Mario Martínez GaldámezEndovascular Neurosurgery/Interventional Neuroradiology, Hospital Clínico Universitario de Valladolid, Valladolid, Castilla y León, Spain.
Markus HoltmannspötterNeuroradiology, Rigshospitalet, Copenhagen, Denmark.
Laurent SpelleInterventional Neuroradiology, Hôpital Bicêtre, Le Kremlin-Bicetre, Île-de-France, France.
Konstantinos LagiosInterventional Neuroradiology, 251 Air Force General Hospital, Athens, Attica, Greece.
Maria RuggieroNeuroradiology, Maurizio Bufalini Hospital, Cesena, Emilia-Romagna, Italy.ORCID http://orcid.org/0000-0002-3612-4289
Pedro VegaRadiology, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain.
Hemant SonwalkarNeuroradiology, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.
René ChapotDepartment of Intracranial Endovascular Therapy, Alfried Krupp Krankenhaus Ruttenscheid, Essen, Nordrhein-Westfalen, Germany.
Saleh LaminInterventional Neuroradiology. Radiology, Queen Elizabeth Hospital, Birmingham, Birmingham, UK.
Alfried Krupp Hospital · DEBicêtre Hospital · FRGold Coast Hospital · AUHellenic Air Force · GRHospital Clínico Universitario de Valladolid · ESHospital Universitario Central de Asturias · ESLancashire Teaching Hospitals NHS Foundation Trust · GBOspedale “M. Bufalini” di Cesena · ITQueen Elizabeth Hospital Birmingham · GBRigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.

methodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.

resultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.

conclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02719522.

Indexed as

AdultAgedBlood Vessel ProsthesisEmbolization, TherapeuticFemaleFollow-Up StudiesHumansIntracranial AneurysmMaleMiddle AgedPerioperative CareProduct Surveillance, PostmarketingProspective StudiesRetreatmentStrokeTime Factorsaneurysmflow diverter

Identifiers

PMID32482834
PMCPMC7569365
OpenAlexW3030034620

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.