Table 2

Primary and secondary safety outcomes at 1-year post-procedure

EndpointEvent rate n/N (%) (95% CI)
Major stroke in the territory supplied by the treated artery or neurological death0/50 (0%) (0%, 5.8%)
Major stroke in the territory supplied by the treated artery0/50 (0%) (0%, 5.8%)
Neurological death0/50 (0%) (0%, 5.8%)
Pipeline Flex embolization device with shield technology-related neurologic adverse event rate7/50 (14.0%) (5.8%, 26.7%)