Primary safety and efficacy endpoint rate through 12-month' follow-up (CEC adjudicated)
| Endpoint | Summary statistics (n=116) | 95% CI | Performance goal | P value* |
| Primary efficacy endpoint† | 76.7% | (67.0% to 86.5%) | 50% | <0.001 |
| Primary safety endpoint | 5 (4.3%) | (1.4% to 9.8%) | 25% | <0.001 |
| Major ipsilateral stroke | 4 (3.4%) | (0.9% to 8.6%) | ||
| Neurologic death | 1 (0.9%) | (0.0% to 4.7%) |
*One-sided binomial exact test of success against the performance goal at 12 months (α=0.025).
†Multiple imputation for missing data.
CEC, Clinical Events Committee.