Primary safety event definitions in the three trials
| Study | Primary safety event definitions |
| ATLAS | Any major ipsilateral stroke or neurological death within 12 months following the procedure. An ipsilateral stroke was defined as an acute episode of focal or global neurological dysfunction due to brain or retinal infarction or due to an intracranial hemorrhage inclusive of subarachnoid, intraventricular, or intraparenchymal hemorrhage, occurring in the same hemisphere as the target aneurysm. A major ipsilateral stroke was defined as an ipsilateral stroke with an increase of ≥4 points on the National Institutes of Health Stroke Scale assessment at 24 hours after symptoms onset |
| WEB-IT | Proportion of subjects with death of any non-accidental cause or any major stroke (an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale as of day 7 post onset) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 after treatment. A major stroke is a stroke which increased the National Institutes of Health Stroke Scale score by ≥4, at the time of assessment and which remained present after 7 days |
| LVIS | Primary safety composite rate (disabling stroke with modified Rankin Scale score ≥3 within 12 months at any time point between 90 days and last available follow‐up or neurological death) |
ATLAS, Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System; LVIS, Pivotal Study of the Low Profile Visualized Intraluminal Support; WEB-IT, Woven EndoBridge Intrasaccular Therapy Study.