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

Study Overview
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Brief Summary
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To determine if the Trevo Retriever is as good or better than the Merci Retriever in restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a large vessel.

Detailed Description
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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.

Official Title
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Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Mechanical Thrombectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Merci Retriever<br>Merci Retriever is the predicate product that received FDA clearance in 2004. Merci Retriever a first generation mechanical thrombectomy device intended to remove clot and restore blood flow in a neurovascular vessel in the setting of acute ischemic stroke. | Device: Mechanical Thrombectomy<br>* Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.<br>|
| Experimental: Trevo Stentriever<br>Trevo Retriever is a second generation mechanical thrombectomy device intended to remove clot and restore blood flow in a neurovascular vessel in the setting of acute ischemic stroke. The Trevo Retriever is a type of stent, specifically design to allow for clot integration into the device. The clot in the retriever is then removed and blood flow is restored. | Device: Mechanical Thrombectomy<br>* Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint | Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device. Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ... Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed] | acute/procedural | 
| Primary Safety Endpoint | Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours). | within 24 hours of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint | Good clinical outcomes at 90 days, as assessed by mRS (a good clinical outcome is defined as mRS </= 2) mRS 0-2 indicates functional independence 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Sca | 90 days | 
| Secondary Endpoint | All cause mortality at 90 days | procedure through 90 days | 
| Secondary Endpoint | Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain, Ischemia, Stroke, Ischemic Stroke, Mechanical Thrombectomy, Brain clot, Cerebrovascular disease, Recanalization, Revascularization