TY - JOUR
T1 - Safety and efficacy of the eCLIPs bifurcation remodelling system for the treatment of wide necked bifurcation aneurysms
T2 - 1 year results from the European eCLIPs Safety, Feasibility, and Efficacy Study (EESIS)
AU - de Vries, Joost
AU - Aquarius, René
AU - Sørensen, Leif
AU - Boogaarts, Hieronymus D
AU - Turowski, Bernd
AU - van Zwam, Wim H
AU - Marotta, Thomas R
AU - Bartels, Ronald H M A
N1 - © Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/2
Y1 - 2023/2
N2 - 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 followup. 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.
AB - 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 followup. 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.
KW - DEVICE
KW - EMBOLIZATION
KW - INTRACRANIAL ANEURYSMS
KW - STENT-ASSISTED COILING
U2 - 10.1136/neurintsurg-2021-018460
DO - 10.1136/neurintsurg-2021-018460
M3 - Article
C2 - 35393338
SN - 1759-8478
VL - 15
SP - 163
EP - 171
JO - Journal of Neurointerventional Surgery
JF - Journal of Neurointerventional Surgery
IS - 2
ER -