Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke

Inclusion criteria

• Age ≥ 18 years old
• Clinical signs consistent with acute ischemic stroke
• No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
• NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE
• Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE.
• Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours
• Subject or legally authorized representative has provided informed consent on data collection, and consent is documented

Exclusion criteria

• Life expectancy of less than 90 days
• Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation)
• Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
• Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
• Known bleeding diathesis:

• Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) > 3;
• Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or
• Platelet count < 100,000/mm3
• Glucose <50 mg/dL (2.8 mmol, 2.6mM)
• Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management
• Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents
• Pregnancy or lactating female
• Subject already enrolled in a clinical study involving experimental medication or device

Imaging Exclusion criteria:

• CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor.
• Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis
• Blood vessel with extreme tortuosity or other conditions preventing the access of the device.