Table 4:

Major protocol violations

ResultNo Major Protocol Violations (N = 73)Major Protocol Violation(s) (N = 38)*P Value
Procedure-related serious adverse events, N (%)4 (5.5)7 (18.4).044
Intracranial hemorrhage
    Symptomatic ICH, N (%)7 (9.6)3 (7.9)>.99
    Symptomatic SAH, N (%)2 (2.7)1 (2.6)>.99
    Asymptomatic ICH, N (%)20 (27.4)13 (34.2).514
    Asymptomatic SAH, N (%)3 (4.1)5 (13.1).120
mRS ≤2 at 90 d, N (%)24 (33.3)13 (36.1)>.99
Mortality at 90 d, N (%)20 (27.8)13 (36.1).514
  • Note:—ICH indicates intracranial hemorrhage; SAH, subarachnoid hemorrhage; mRS, modified Rankin score.

  • * Protocol violations are tabulated per patient.

  • Fisher exact test.

  • N = 72 in no protocol violations group and 36 in the protocol violation group at 90 days.