Table 3. Safety endpoints in the intention-to-treat population.

Parameter	Total (n=139)
Primary safety composite endpoint
Percent of subjects deceased at day 90 and/or experiencing sICH at 24 hours postprocedure, n (%)	17 (12.2%)
95% CI	(7.8% to 18.7%)
Secondary and other safety endpoints
Percent of subjects deceased at day 90	13/138* (9.4%)
	(95% CI 5.6% to 15.5%)
Percent of subjects experiencing sICH at 24 hours postprocedure	7 (5.0%)
	(95% CI: 2.5% to 10.0%)
Percent of subjects with ≥4 point increase in NIHSS score at 24 hours postprocedure	7 (5.0%)
	(95% CI 2.5% to 10.0%)
Percent of subjects with ≥4 point increase in NIHSS score at day 5–10/discharge	4 (2.9%)
	(95% CI 1.1% to 7.2%)
Procedure-related serious adverse events, n (%)	8 (5.8%)
NeVa device-related serious adverse events, n (%)	6 (4.3%)

^*One subject lost to follow-up at Dday 90.

.NIHSS, National Institutes of Health Stroke Scale; sICH, symptomatic intracranial hemorrhage