Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)

Inclusion Criteria:

• The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
• Aged between 18 years and 80 years (inclusive).
• A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
• NIHSS score ≥8 and ≤25.
• Pre-ictal mRS score of 0 or 1.
• Angiographic confirmation of an occlusion of an ICA (including T and L occlusions), M1 or M2, MCA, or BA with TICI flow of 0-1.
• Confirmation by the interventionalist, after screening CT or MRI, that the treatment site can be accessed with the Neuravi device.

• The interventionalist estimates that at least one deployment of the Neuravi device can be completed within 5 hours from the onset of symptoms, or if time of onset of symptoms is unknown or > 5 hours, patients can be included using imaging with the following criteria:

  1. MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and mismatch between perfusion reduction and diffusion restriction present.
  2. CT criterion: ASPECTS 8 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤30 mL and mismatch between perfusion reduction and low CBV present.

Exclusion Criteria:

• Life expectancy of less than 6 months.
• Females who are pregnant or lactating.
• History of severe allergy to contrast medium.
• Has suffered a stroke in the past three months.
• The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
• Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0.
• Platelet count < 50,000.
• Glucose < 50 mg/dL.
• Heparin use in previous 24 hours with PTT or ACT > 2X normal.
• Any known hemorrhagic or coagulation deficiency.
• Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
• For basilar artery occlusion, extended early ischemic changes as confirmed by pc-ASPECTS ≤ 7 on baseline CT or CTA-source images, or extensive DWI lesions in the midbrain or pons regions on pre-treatment MRI.
• Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma).
• Excessive arterial tortuosity that precludes the study device from reaching the target vessel.
• A proximal stenosis or complete occlusion that cannot, as judged by the responsible interventionalist, be treated safely or which prevents access to the occluded vessel with the Neuravi device.
• Evidence of active infection.
• Known cancer with metastases
• Current use of cocaine or other vasoactive substance.