Table 4.

Secondary safety endpoints through 12-month follow-up

Secondary safety endpoint	Summary statistics (n=116)	95% CI
New or worsening major ipsilateral stroke (CEC-adjudicated)	4 (3.4%)	(0.9% to 8.6%)
Subarachnoid hemorrhage (CEC-adjudicated)*	2 (1.7%)	(0.2% to 6.1%)
Aneurysm rupture (CEC-adjudicated)*	1 (0.9%)	(0.0% to 4.7%)
Device-related serious adverse event (site-reported)	11 (9.5%)	(4.8% to 16.3%)

Data are n (%).

*One subject experienced a serious adverse effect (SAE) on postoperative day 1 that was site-reported as ‘vessel dissection related to subarachnoid hemorrhage (SAH)’ and possibly related to the device and was CEC-adjudicated as a major ipsilateral stroke, aneurysm rupture, and SAH’. This single event is therefore captured in four separate secondary endpoint categories (ie, new or worsening ipsilateral stroke, SAH, aneurysm rupture, and device-related SAE).

CEC, Clinical Events Committee.