IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.MethodsOne-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.ResultsOne-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.ConclusionsThe prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.Trial registration number
NCT02191618
High maximum SBP levels following MT are independently associated with increased likelihood of 3-month mortality and functional dependence in LVO patients. Moderate BP control is also related to lower odds of 3-month mortality in comparison to permissive hypertension.
Background and Purpose-The ability to discriminate between ruptured and unruptured cerebral aneurysms on a morphological basis may be useful in clinical risk stratification. The objective was to evaluate the importance of inflow-angle (IA), the angle separating parent vessel and aneurysm dome main axes. Methods-IA, maximal dimension, height-width ratio, and dome-neck aspect ratio were evaluated in sidewall-type aneurysms with respect to rupture status in a cohort of 116 aneurysms in 102 patients. Computational fluid dynamic analysis was performed in an idealized model with variational analysis of the effect of IA on intra-aneurysmal hemodynamics. Results-Univariate analysis identified IA as significantly more obtuse in the ruptured subset (124.9°Ϯ26.5°versus105.8°Ϯ18.5°, Pϭ0.0001); similarly, maximal dimension, height-width ratio, and dome-neck aspect ratio were significantly greater in the ruptured subset; multivariate logistic regression identified only IA (Pϭ0.0158) and height-width ratio (Pϭ0.0017), but not maximal dimension or dome-neck aspect ratio, as independent discriminants of rupture status. Computational fluid dynamic analysis showed increasing IA leading to deeper migration of the flow recirculation zone into the aneurysm with higher peak flow velocities and a greater transmission of kinetic energy into the distal portion of the dome. Increasing IA resulted in higher inflow velocity and greater wall shear stress magnitude and spatial gradients in both the inflow zone and dome. Conclusions-Inflow-angle is a significant discriminant of rupture status in sidewall-type aneurysms and is associated with higher energy transmission to the dome. These results support inclusion of IA in future prospective aneurysm rupture risk assessment trials. (Stroke.
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