Table 1.

Efficacy and safety assessment (simplified).

Primary efficacy outcome

Substantial angiographic recanalization (mTICI 2b/2c/3) or absence of retrievable thrombus on the initial angiogram

Secondary efficacy outcomes

≥8 points reduction in NIHSS score or reaching 0–1 at 72 hours after thrombolysis

Modified Rankin Scale (mRS) score at 90 days

Safety outcome

sICH within 24–36 hours

Major bleeding within 90 days

Mortality at 90 days

SAEs within 90 days

In the safety confirmation phase, the above four safety outcomes plus severe adverse events (SAEs) and symptomatic intracranial hemorrhage (sICH) within 72 hours will be assessed.

mTICI, modified treatment in cerebral infarction; NIHSS, National Institutes of Health Stroke Scale