Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Acute Ischemic Stroke within 24 hours
2. Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
3. NIHSS ≥7 - ≤22

Exclusion Criteria

1. >24hours from symptom onset to time of treatment
2. Evidence of intracranial, subdural, or subarachnoid hemorrhage
3. Clinical presentation of intracranial hemorrhage
4. Pre stroke ≥3 mRS
5. The presence of a brainstem or cerebellar stroke
6. Transient Ischemic Attack (TIA)
7. Seizure at stroke onset
8. Blood glucose >400 or <60
9. Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG
10. Septic embolus
11. CNS tumor (except asymptomatic meningioma)
12. Dermatologic condition of the scalp (e.g. Psoriasis)
13. Thrombolytic therapy
14. Head implant (e.g. Clipped aneurysm, Hakim valve)