REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke

The investigation is a prospective, single-arm, multi-center clinical study. The study will be conducted in up to 40 investigational sites in the US, Canada, and Europe. This study will enroll up to 200 subjects, with a maximum enrollment of 30 subjects per site.

Inclusion criteria

• Age ≥18 years on the date of consent
• National Institutes of Health Stroke Score (NIHSS) ≥6
• Alberta Stroke Program Early CT Score (ASPECTS) ≥6 assessed within 120 minutes before arterial access, defined by either baseline non-contrast computed tomography (NCCT) or baseline diffusion-weighted magnetic resonance imaging (DW-MRI)
• Angiographically suitable for endovascular intervention and the interventionalist estimates that arterial access can be achieved within 8 hours from time last known well
• Independent status immediately pre-stroke defined as ability to perform all activities of daily living as defined by mRS 0-1
• Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 segment technically accessible, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter
• Subject or legally authorized representative (LAR) is willing and able to provide informed consent, as evidenced by signing and dating the IRB-approved informed consent form prior to initiation of any study-specific procedures
• Willing and able to comply with the protocol-specified procedures and assessments

Exclusion criteria

• Any intracranial hemorrhage at baseline
• Previous stroke within 90 days
• Female who is pregnant or lactating or has a positive pregnancy test at time of admission
• Arterial occlusive lesion is not technically amenable to recanalization, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter (e.g., an extracranial carotid lesion prevents access, evidence of carotid dissection)
• Clinical symptoms or non-invasive imaging suggestive of or confirming bilateral stroke or stroke in multiple territories defined as multiple large vessel occlusions (e.g., bilateral proximal MCA occlusions)
• Comorbid illness that would confound the neurological or functional evaluation or is severe enough (e.g., metastatic cancer, severe congestive heart failure) such that life expectancy is <1 year or the 90-day outcome is likely to be determined by the comorbid illness
• Any contraindication to endovascular thrombectomy, such as a known history of severe contrast allergy or absolute contraindication to iodinated contrast
• Participation in another clinical trial involving an investigational mechanical device (subjects may be co-enrolled in a registry study where there is no investigational treatment).