A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial

Inclusion Criteria:

- From 18 to 85 years of age.

- Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1)(TICI 0-1)
from CT Angiography. Target vessel occlusion may include the anterior circulation.

- Presented with symptoms consistent with acute ischemic stroke within 8 hours of
symptom onset. Patients who presented within 3 hours must be ineligible or refractory
to IV rtPA therapy.

- At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS)
score greater than 10

- Known core infarct volume assessed by CTP, CTA or DWI scans

Exclusion Criteria:

- History of stroke in the past 3 months.

- Pre-existing neurological or psychiatric disease that could confound the study
results such as a pre-stroke mRS score greater than 1

- Known severe allergy to contrast media

- Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg
or diastolic blood pressure less than 110 mmHg)

- CT evidence of the following conditions before enrollment:

- Significant mass effect with midline shift

- Evidence of intracranial hemorrhage

- Treated with endovascular therapy for acute stroke

- Life expectancy less than 90 days

- Participation in another clinical investigation that could confound the evaluation of
the study