Table 2

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 CEC1.5% (3/204)
Device-related SAEs at 30 days: per CEC2.0% (4/204)
Procedure-related SAEs at 24 hours: per CEC3.4% (7/204)
Procedure-related SAEs at 30 days: per CEC4.4% (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 CEC1.5% (3/204)
Vessel damage: per CEC2.9 % (6/204)
 Vessel perforation0.5 % (1/204)
 Vessel dissection2.5% (5/204)
Symptom onset to ASPECTS CT/MRI, minutes137.9±71.0 (204) (mean±SD)
127.5/81.5–188.0 (median/IQR)
Imaging to arterial puncture, minutes72.2±44.2 (204) (mean±SD)
61.5/41.0–91.5 (median/IQR)
Arterial puncture to revascularization, minutes40.1±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 days4.7±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.