Table 3.
Safety outcomes.
| Safety outcomes (CEC and/or Core Lab adjudicated) | RapidPulseTM, ITT (N = 40) | Control arm (N = 40) |
|---|---|---|
| Symptomatic ICH at 24 h — no. (%) | 0 (0.0%) | 1 (2.5%) |
| Mortality — no. (%) | 6 (15.0%) | 8 (20.0%) |
| Embolism in new territory — no. (%) | 1 (2.6%) | 1 (2.5%) |
| Any intracranial hemorrhage at 24 h — no. (%) | 13 (33.3%) | 18 (45.0%) |
| Hemorrhagic transformation at 24 h — no. (%) | ||
| All subtypes | 13 (32.5%) | 18 (45.0%) |
| HI-1 | 3 (7.5%) | 2 (5%) |
| HI-2 | 0 (0%) | 0 (0%) |
| PH-1 | 4 (10%) | 7 (17.5%) |
| PH-2 | 3 (7.5%) | 8 (20%) |
| SAH | 3 (7.5%) | 1 (2.5%) |
CEC: clinical event committee; ITT: intent to treat.