Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke

The TREVO 2 protocol was designed to assess the safety and effectiveness of the Trevo
Retriever device and determine if it is substantially equivalent to the predicate Merci
Retriever. The trial utilized a Primary Effectiveness Endpoint of revascularization and a
composite Primary Safety Endpoint that included procedure-related serious adverse events
occurring within 24 hours of the procedure. Subjects who presented to enrolling centers with
large ischemic strokes were screened for eligibility in the study. If a subject met
eligibility criteria, then Informed Consent was obtained prior to commencing the angiogram.
If all inclusion/exclusion criteria were confirmed, including the angiographic criteria,
then the subject was randomized.The Primary Effectiveness Endpoint was successful
revascularization of the target occlusion, using the TICI score. Success was determined by
the central Core Lab.The Primary Safety Endpoint is a composite endpoint, described in the
protocol as the "Incidence of procedure-related serious adverse events (PRSAEs) through 24
hours post procedure (-6/+12 hours) defined as: vascular perforation or intramural arterial
dissection, symptomatic ICH, embolization to a previously uninvolved territory, access site
complication requiring surgical repair or blood transfusion, intra-procedural mortality,
device failure (in vivo breakage), or any other complications judged by the Clinical Events
Committee (CEC) to be related to the procedure."

Key Inclusion Criteria:

- Patient presenting with clinical signs and symptoms consistent with a diagnosis of
Acute Ischemic Stroke, and:

- Patient has failed IV t-PA therapy Or

- Patient is contraindicated for IV t-PA administration

- NIHSS 8 < NIHSS < 29

- Anticipated life expectancy of at least 6 months

- No significant pre-stroke disability (mRS < 1)

- Written informed consent to participate given by patient or legal representative

- Angiographic confirmation of a persistent large vessel occlusion in the internal
carotid, middle cerebral (M1 and/or M2 segments), basilar and/or vertebral arteries

- Treatable within 8 hours of symptom onset, defined as the first pass being made with
the assigned study device

Key Exclusion Criteria:

- Abnormal blood pressure and/or blood coagulation lab values

- Pregnancy

- Patient participating in another investigational drug or device study

- More than 1/3 of MCA or equivalent in non-MCA territory

- Baseline evidence of significant mass effect with midline shift, or hemorrhage, or
intracranial tumor

- Bilateral stroke