Abstract Background Woven EndoBridge (WEB™) has been shown to be safe and effective in the treatment of wide-necked bifurcation aneurysms (WNBAs). However, the use of this device has not been studied in China. This study assessed safety and effectiveness of WEB for the treatment of intracranial WNBAs in a Chinese population. Methods The WEB Intrasaccular Therapy China Study (WEB-IT China) was a prospective, single-arm study allowing enrollment of adult WNBA patients treated with the WEB device between June 2017 and August 2019 among 8 centers in China. The primary effectiveness endpoint was treatment success rate, defined as complete aneurysm occlusion without retreatment, recurrent subarachnoid hemorrhage (SAH), or >50% parent artery stenosis at 1 year. The primary safety endpoint was the proportion of patients with major adverse event (MAE) incidence at 1 year follow-up, including non-accidental death or any major stroke within 30 days, or major ipsilateral stroke, or neurological death from day 31 to 1 year after treatment. Results A total of 60 patients with 60 unruptured aneurysms were enrolled. Technical success rate was 98.3% (59/60). At 1 year, the treatment success rate was 54.2% (26/48), and two patients (3.9%) experienced an MAE, which was not device related. At 1 year, the complete occlusion rate was 56% and adequate occlusion rate was 82%. There were no retreatments, new bleeding events, or mortalities. Conclusions This study demonstrated that the WEB device is safe and effective in the treatment of WNBAs in the Chinese population. Trial registration Clinicaltrials.gov Unique Identifier NCT03207087.
He et al. (Tue,) studied this question.