Primary and secondary endpoints
| Outcome | % (n/N) |
| Primary endpoints | |
| mTICI 2b-3 at post-procedure: per core laboratory* | 93.1% (190/204) |
| mRS 0–2 at 90 days† | 61% (122/200) |
| Secondary endpoints | |
| Neurologic improvement‡ | 67.9% (127/187) |
| Device-related SAEs at 24 hours: per CEC | 1.5% (3/204) |
| Device-related SAEs at 30 days: per CEC | 2.0% (4/204) |
| Procedure-related SAEs at 24 hours: per CEC | 3.4% (7/204) |
| Procedure-related SAEs at 30 days: per CEC | 4.4% (9/204) |
| All-cause mortality at 90 days§ | 7.5% (15/200) |
| Morbidity at 90 days|| | 31.5% (63/200) |
| Symptomatic intracranial hemorrhage at 24 hours: per CEC# | 2.9% (6/204) |
| Embolization of new territory: per CEC | 1.5% (3/204) |
| Vessel damage: per CEC | 2.9 % (6/204) |
| Vessel perforation | 0.5 % (1/204) |
| Vessel dissection | 2.5% (5/204) |
| Symptom onset to ASPECTS CT/MRI, minutes | 137.9±71.0 (204) (mean±SD) 127.5/81.5–188.0 (median/IQR) |
| Imaging to arterial puncture, minutes | 72.2±44.2 (204) (mean±SD) 61.5/41.0–91.5 (median/IQR) |
| Arterial puncture to revascularization, minutes | 40.1±27.2 (204) (mean±SD) 31.0/20.0–53.0 (median/IQR) |
| EQ-5D-3L VAS improvement at 90 days compared with 7–10 days | 4.7±20.4 (119) (mean±SD) 5/0–15 (median/IQR) |
Data are % (n/N) or mean ±SD (N) (median) (IQR). ASPECTS, Alberta Stroke Program Early CT Score; CEC, Clinical Events Committee; CI, confidence interval; IQR, interquartile range; mRS, modified Rankin Scale; mTICI, modified Thrombolysis in Cerebral Infarction; SAE, serious adverse event.
*For two patients missing Core Laboratory DSA review due to vessel not visualized, PI assessment of mTICI score carried over.
†Four patients withdrew prior to the 90-day follow-up and were excluded from 90-day mRS analysis.
‡Good functional neurological recovery defined as a reduction of 10 or more points in the median NIHSS or a score of 0–1 at 7–10 days. Seventeen patients did not have 7–10 day NIHSS assessment.
§Mortality assigned as 90-day mRS 6.
¶Morbidity defined as 90-day mRS 3–5.
**Defined as 24 hours CT evidence of an ECASS-defined intracranial hemorrhage associated with a 4-point or more worsening of the NIHSS score.