BACKGROUND AND PURPOSE: Flow disruption with the Woven EndoBridge (WEB) device is an innovative technique for the endovascular treatment of wide-neck bifurcation aneurysms. The initial version of the device (WEB Double-Layer) was evaluated in the WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST) study, whereas the French Observatory study evaluated both WEB Double-Layer and Single-Layer versions of the device. WEBCAST 2 was designed to evaluate the WEB Single-Layer with Enhanced Visualization. MATERIALS AND METHODS: Patients with wide-neck bifurcation aneurysms for which WEB treatment was possible were included. Clinical data including adverse events and clinical status at 1 month and 1 year were collected and analyzed. A core laboratory evaluated anatomic results at 1 year following the procedure. RESULTS: Ten European neurointerventional centers included 55 patients (38 women; 27–77 years of age; mean, 54.4 ± 10.0 years) with 55 aneurysms. Aneurysm locations were the middle cerebral artery in 25 aneurysms (45.5%), the anterior communicating artery in 16 (29.1%), the basilar artery in 9 (16.4%), and the internal carotid artery terminus in 5 (9.1%). Procedural morbidity and mortality at 1 month were, respectively, 1.8% (1/55 patients) and 0.0% (0/55 patients). Morbidity and mortality at 1 year were, respectively, 3.9% (2/51 patients) and 2.0% (1/51 patients). At 1 year, complete occlusion was observed in 27/50 aneurysms (54.0%); neck remnant, in 13/50 (26.0%); and aneurysm remnant, in 10/50 (20.0%) (adequate occlusion in 40/50, 80.0%). CONCLUSIONS: WEBCAST 2 confirms the high safety and efficacy of WEB aneurysm treatment demonstrated in the WEBCAST and French Observatory studies.

Background The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. Methods The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. Results Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. Conclusions The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.