Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

Eligibility Criteria

• * Aged 18 years or older.
• * Body weight of less than 150 kg.
• * AIS intended for immediate endovascular treatment.
• * Disabling stroke defined as a baseline NIHSS ≥6 at the time of randomization.
• * Confirmed symptomatic intracranial occlusion, based on qualifying imaging, at one or more of the following locations: intracranial carotid artery and/or M1 middle cerebral artery.
• * Onset of AIS (last time subject seen well) to randomization is ≤16 hours.
• * Intended endovascular treatment with an approved endovascular device.
• * Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual.
• * Poor/no collateral circulation. (e.g. collateral score of 0 or 1).
• * ASPECT score of 0-4.
• * Current AIS is being treated with IV thrombolytic therapy (eg, alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours.
• * Intent to use any endovascular thrombectomy device that is not FDA-approved.
• * Planned use of intra-arterial thrombolytic therapy.
• * Known severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
• * Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
• * Known arterial condition that would prevent the mechanical device from achieving reperfusion (eg, aortic dissection, carotid stent).
• * Subjects with end-stage kidney disease.
• * Subjects taking a chronic anticoagulant (eg, warfarin, apixaban).
• * Known metastatic malignancy with poor prognosis.
• * Subjects with any comorbid disease, condition, or situation that would confound the neurologic and functional evaluations, prevent improvement, or render the subject unable to complete follow-up treatment, in the opinion of the investigator.
• * Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion.
• * Subject has previously received scp776 in another clinical trial.