Major protocol violations
| Result | No 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.