Evidence map›Paper›PMID 37914392›Full record

Observational studyJournal of neurointerventional surgery2024

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms.

Laurent Spelle, Vincent Costalat, Jildaz Caroff, Fritz Wodarg, Sebastian Fischer, Denis Herbreteau, Markus A Möhlenbruch, Anne-Christine Januel, Chrysanthi Papagiannaki, Joachim Klisch and 17 more

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

Observational study in Journal of neurointerventional surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03844334 (CLEVER), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

NCT03844334 completednot on this map

CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

TypeobservationalSponsorMicrovention-Terumo, Inc.Ran2019 to 2022Enrolled163ConditionsBrain AneurysmArmsWEB Aneurysm Embolization System
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 19 citations in OpenAlex.

  1. Observational
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Observational
  11. The impact of pre-treatment aneurysm angulation. What happens with WEB devices at follow-up?Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025
    Article
  12. Article
  13. Review
  14. 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

27 authors at 19 institutions in 5 countries.

Laurent SpelleNEURI The Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, France laurent@spelle.fr.ORCID http://orcid.org/0000-0002-6748-8528
Vincent CostalatInterventional Neuroradiology, Gui de Chauliac University hospital, Montpellier, France.
Jildaz CaroffNEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.ORCID http://orcid.org/0000-0002-0029-1835
Fritz WodargDepartment of Radiology and Neuroradiology, Universitatsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany.ORCID http://orcid.org/0000-0003-1413-2699
Sebastian FischerNeuroradiology, Ruhr-Universität Bochum Medizinische Fakultät, Bochum, Nordrhein-Westfalen, Germany.
Denis HerbreteauInreventional Neuroradiology, Centre Hospitalier Universitaire de Tours, Tours, France.
Markus A MöhlenbruchNeuroradiology, UniversitätsKlinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany.
Anne-Christine JanuelDiagnostic and Therapeutic Neuroradiology, Hospital Pierre Paul Riquet, Toulouse, Occitanie, France.
Chrysanthi PapagiannakiInterventional Neuroradiology, CHU de Rouen, Rouen, Normandie, France.ORCID http://orcid.org/0000-0002-9473-9644
Joachim KlischNeuroradiology, HELIOS Klinikum Erfurt, Erfurt, Thüringen, Germany.
Jussi NumminenInterventional Neuroradiology, Helsinki University Central Hospital, Helsinki, Uusimaa, Finland.
Riitta RautioDepartment of Radiology, TYKS, Turku, Finland.ORCID http://orcid.org/0000-0001-8385-0622
Ansgar BerlisDepartment of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Augsburg, Augsburg, Bayern, Germany.
Cristian MihaleaNEURI The Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, France.ORCID http://orcid.org/0000-0002-8260-8284
Vanessa ChalumeauNEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.ORCID http://orcid.org/0000-0002-7753-7186
Jonathan DownerDepartment of Clinical Neurosciences, Royal Infirmary of Edinburgh, Edinburgh, UK.ORCID http://orcid.org/0000-0002-8272-092X
Jonathan CorteseBicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.
Léon IkkaNEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.
Sophie GallasNEURI the Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, Île-de-France, France.
Maxim BesterDepartment of Diagnostic and Interventional Neuroradiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Hamburg, Germany.
Thomas LiebigNeuroradiology, LMU, Munchen, Germany.ORCID http://orcid.org/0000-0001-5640-7780
Stéphane VelascoNeuroradiology, CHU Poitiers, Poitiers, France.
Lamiae GrimaldiClinical Research Unit Bicetre hospital, Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, Île-de-France, France.
James ByrneDepartment of Neuroradiology, John Radcliffe Hospital, Oxford, Oxfordshire, UK.
Istvan SzikoraInterventional Neuroradiology, National Institute of Clinical Neurosciences, Budapest, Budapest, Hungary.ORCID http://orcid.org/0000-0003-3730-3278
Laurent PierotDepartment of Interventional Neuroradiology, CHU de Reims, Reims, Grand Est, France.ORCID http://orcid.org/0000-0002-2523-4909
Christophe CognardDiagnostic and Therapeutic Neuroradiology, Hôpital Pierre Paul Riquet, Toulouse, Occitanie, France.ORCID http://orcid.org/0000-0003-4287-2627
Université Paris-Saclay · FRHôpital Paule de Viguier · FRCentre Hospitalier Universitaire de Poitiers · FRCentre Hospitalier Universitaire de Reims · FRCentre Hospitalier Universitaire de Rouen · FRCentre Hospitalier Universitaire de Tours · FRCentre National de la Recherche Scientifique · FREdinburgh Royal Infirmary · GBHeidelberg University · DEHelios Klinikum Erfurt · DEHelsinki University Hospital · FIHôpital Gui de Chauliac · FRJohn Radcliffe Hospital · GBLMU Klinikum · DEOrszágos Idegsebészeti Tudományos Intézet · HURuhr University Bochum · DEUniversität Hamburg · DEUniversity Hospital Augsburg · DEUniversity Hospital Schleswig-Holstein · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms.

methodsThe CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months.

resultsA total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed.

conclusionEndovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. TRIAL REGISTRATION NUMBER: NCT03844334.

Indexed as

Aneurysm, RupturedEndovascular ProceduresIntracranial AneurysmFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesTreatment Outcomeaneurysmangiographydeviceinterventionsubarachnoid

Identifiers

PMID37914392
PMCPMC11671992
OpenAlexW4388126346

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.