Multicenter Experience and Diameter Analysis of the Low-profile Visualized Intraluminal Support EVO™ in the Treatment of Unruptured Intracranial Aneurysms.

Abstract

The Low-Profile Visualized Intraluminal Support EVO stent enables full fluoroscopic visualization and provides higher metal coverage than conventional devices used to assist coil embolization of wide-neck unruptured intracranial aneurysms. We conducted a prospective multicenter clinical trial to assess its efficacy and safety in stent-assisted coil embolization. A total of 41 patients were enrolled across 6 centers. The primary endpoint of clinical success was achieved in 39 of 40 implanted cases (97.5%; 95% confidence interval, 86.8%-99.9%). These findings demonstrate the efficacy and safety of Low-Profile Visualized Intraluminal Support EVO as an assist stent for wide-neck aneurysms. Given that concerns remain regarding thrombotic risk with small-diameter devices (2.5-3.0 mm), a subgroup analysis comparing the results of small-diameter Low-Profile Visualized Intraluminal Support EVO (2.5-3.0 mm) versus those of larger Low-Profile Visualized Intraluminal Support EVO (3.5-4.0 mm) was conducted. Fifteen cases were included in the small-diameter group, and 25 were included in the comparative group. Ischemic events occurred in 1 of 15 (6.7%) patients in the small-diameter group and in 2 of 25 (8.0%) patients in the larger-diameter group, with no statistically significant difference between the 2 groups, and all events were transient or asymptomatic. At 6 months, 13 of 14 (92.9%) patients in the small-diameter group achieved complete occlusion (Raymond-Roy Class I, core laboratory adjudicated). Overall, small-diameter Low-Profile Visualized Intraluminal Support EVO did not confer a significantly higher risk of ischemic complications compared with larger-diameter devices and demonstrated favorable therapeutic potential for the treatment of wide-neck aneurysms. Trial registration: jRCT2042230075.