Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke

Exclusion Criteria

• •1. Evidence of a large core of established infarction defined as ASPECTS 0-4.
• •2. Evidence of absence of collateral circulation on CTA (Collateral score of 0 or 1).
• •3. Intent to use any endovascular device other than a stent retriever or clot aspiration device or intra-arterial medications as the initial thrombectomy approach.
• •4. Intent to use any intravenous thrombolytic other than alteplase if intravenous thrombolysis is planned.
• •5. No femoral pulses, very difficult endovascular access or extreme tortuosity of great vessels that is predicted to result in an inability to deliver timely endovascular therapy. Direct common carotid or radial/brachial/axillary access is permissible.
• •6. Estimated or known weight \> 120 kg or \< 45 kg.
• •7. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive, or breastfeeding.
• •8. Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention, including any contraindications listed in the prescribing information approved by local authorities (e.g., patients with decompensated heart failure as a contraindication for the use of VISIPAQUE™ 270 in Germany).
• •9. 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.
• •10. Prior enrolment in the ESCAPE-NA1 trial or prior receipt of NA-1 for any reason.
• •11. Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or if known a creatinine clearance \< 29 mL/min.
• •12. Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up.
• •13. Patient cannot complete follow-up treatment due to co-morbid non-fatal illness or they are known to be a visitor to the city or any other known reason for which follow-up would be impossible (e.g. incarcerated in a federal prison).
• •14. Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding study inclusion.