The specific aims of this study are to:
1. Determine whether the endovascular treatment (mechanical thrombectomy) alone without
using intravenous (IV) recombinant tissue plasminogen activator (rt-PA) in acute
ischemic stroke patients demonstrates "promise" or a lack thereof ("futility") in
deciding what would be the next phase III trial.
2. Determine the proportion of subjects with slight or no disability (a modified Rankin
score (mRS) of 0-2) at 3 months after receiving endovascular treatment (mechanical
thrombectomy) alone without using IV rt-PA and compare with historical controls who were
treated with IV rt-PA to identify (or lack of) futility.
3. Determine the proportion of subjects with improvement in the National Institutes of
Health Stroke Scale (NIHSS) score of ≥8 points or achieving a score of 0-1 at 24 hours
after the onset of stroke among subjects with acute ischemic stroke after receiving
endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
4. Determine the proportion of subjects with angiographic recanalization on post procedure
angiogram according to modified Thrombolysis in Cerebral Infarction (TICI) perfusion
flow categories among subjects with acute ischemic stroke after receiving endovascular
treatment (mechanical thrombectomy) alone without using IV rt-PA.
5. Determine the proportion of subjects with treatment-related serious adverse events
(SAEs) within 72 hours and development of symptomatic intracranial hemorrhage at 27
±3hrs post treatment among subjects with acute ischemic stroke after receiving
endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.