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  • Safety and efficacy of the eCLIPs bifurcation remodelling system for the treatment of wide necked bifurcation aneurysms: 1 year results from the European eCLIPs Safety, Feasibility, and Efficacy Study (EESIS)

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New devices and techniques
Original research
Safety and efficacy of the eCLIPs bifurcation remodelling system for the treatment of wide necked bifurcation aneurysms: 1 year results from the European eCLIPs Safety, Feasibility, and Efficacy Study (EESIS)
  1. Joost de Vries1,
  2. René Aquarius1,
  3. Leif Sørensen2,
  4. Hieronymus D Boogaarts1,
  5. Bernd Turowski3,
  6. Wim H van Zwam4,
  7. Thomas R Marotta5,
  8. Ronald H M A Bartels1
  1. 1 Neurosurgery, Radboudumc, Nijmegen, Gelderland, The Netherlands
  2. 2 Neuroradiology, Aarhus University Hospital, Aarhus, Denmark
  3. 3 Radiology, Universitätsklinikum Düsseldorf, Dusseldorf, Nordrhein-Westfalen, Germany
  4. 4 Radiology and Nuclear Medicine, Maastricht Universitair Medisch Centrum+, Maastricht, Limburg, The Netherlands
  5. 5 Diagnostic and Therapeutic Neuroradiology, St Michael's Hospital, Toronto, Ontario, Canada
  1. Correspondence to Dr Joost de Vries, Neurosurgery, Radboudumc, 6525 GA Nijmegen, Gelderland, The Netherlands; Joost.deVries{at}radboudumc.nl

Abstract

Background The eCLIPs bifurcation remodelling system is a non-circumferential implant that bridges the neck from outside of a bifurcation aneurysm. The goal of the multicenter, post-marketing European eCLIPs Safety, FeasIbility, and Efficacy Study (EESIS), was to present the efficacy and safety results of the eCLIPs device after 365 days of follow-up.

Methods All patients were to receive an eCLIPs in conjunction with coils. The study was conducted according to good clinical practices and included independent adjudication of safety and efficacy outcomes.

Results Twenty patients were enrolled at four European centers. Mean age was 60 years (range 41–74) and aneurysms were located at the basilar tip (n=19) and carotid tip (n=1). Average aneurysm dome height was 6.0 mm (range 2.0–15.0). Mean neck length was 5.1 mm (range 2.6–8.5). The technical success rate was 90% (18 of 20). No major territorial strokes or deaths occurred between the index procedure and after 365 days of follow-up. Complete occlusion was achieved in 60% of patients (12 of 20 patients) and 67% of patients with an eCLIPs device (12 of 18) after 365 days of follow-up. Adequate occlusion (complete occlusion and neck remnant) was achieved in 80% of patients (16 of 20 patients) and 89% of patients with an eCLIPs device (16 of 18 patients) after 365 days of follow-up.

Conclusion In this small series, treatment with eCLIPs was feasible, safe, and efficacious, considering the challenging nature of the aneurysms.

Trial registration number ClinicalTrials.gov NCT02607501.

  • Aneurysm
  • Brain
  • Device

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. Not applicable.

https://doi.org/10.1136/neurintsurg-2021-018460

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information. Not applicable.

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    Footnotes

    • Contributors Conception and design JDV, TRM, and RHMAB. Data acquisition: JDV, LS, HDB, BT, WHvZ, TRM, and RHMAB. Data analysis and interpretation: RA and JDV. Drafting the manuscript: JDV and RA. Revising the manuscript JDV, RA, LS, HDB, BT, WHvZ, TRM, and RHMAB. Final approval of the submitted manuscript: JDV, RA, LS, HDB, BT, WHvZ, TRM, and RHMAB. Guarantor: JDV.

    • Funding The EESIS was sponsored by Evasc. Study design was chosen in consultation with Evasc.

    • Competing interests JDV: consultant for Stryker Neurovascular and Evasc. LS: consultant for Evasc. HDB: consultant for Stryker Neurovascular and Evasc. WHvZ: speaker fees from Stryker, Cerenovus, and NicoLab; consultancy fees from Philips. TRM: co-inventor of eCLIPs and equity position at Evasc.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.