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)

Abstract

BackgroundThe 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.MethodsAll 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.ResultsTwenty 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.ConclusionIn this small series, treatment with eCLIPs was feasible, safe, and efficacious, considering the challenging nature of the aneurysms.Trial registration numberClinicalTrials.gov NCT02607501.

Endovascular treatment of middle cerebral artery aneurysms: current status and future prospects

“…The eCLIP device is a hybrid device with both neck bridging and flow-diversion properties ( 98 ). Recent studies have confirmed its effect in assisting coiling aneurysms, such as in de Vries et al’s study ( 99 ) and in Diestro et al’s report ( 100 ). The eCLIP device can be used for the treatment of MCA bifurcation aneurysms; however, it has been less frequently reported.…”

“…The eCLIP device is a hybrid device with both neck bridging and flow-diversion properties (98). Recent studies have confirmed its effect in assisting coiling aneurysms, such as in de Vries et al 's study (99) and in Diestro et al 's report (100).…”

Endovascular Treatment of Wide-Neck Bifurcation Aneurysm: Recent Trends in Coil Embolization with Adjunctive Technique

“…In recent studies, complete occlusion and adequate obliteration were archived in 62%–67% and 85%–89%, respectively, during the follow-up period. 47 , 48) The technical success rate of deployment of the eCLIPs was 90%–96%. Procedure-related complications included subarachnoid hemorrhage due to guidewire perforation of the daughter branch, asymptomatic thrombotic events, and vasospasm or dissection due to an eCLIPs microcatheter.…”

“…The proximal Then, the guidewire is advanced intothecontralateralbranchartery.Theribsoftheleaflet segmentallowaccessforthemicrocathetertotheaneurysmalsacforcoiling.Inrecentstudies,completeocclusion andadequateobliterationwerearchivedin62%-67%and 85%-89%,respectively,duringthefollow-upperiod. 47,48) The technical success rate of deployment of the eCLIPs was90%-96%.Procedure-relatedcomplicationsincluded subarachnoidhemorrhageduetoguidewireperforationof the daughter branch, asymptomatic thrombotic events, and vasospasm or dissection due to an eCLIPs microcatheter.TheuniquedesignoftheeCLIPsrequirestheinsertionofacatheterorguidewireintobothdaughterbranches. Therefore, it is important to consider vessel structure, including the diameter of the branch and the angle at which it forms with the parent artery.…”