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

Not Applicable

Completed

Conditions: Ischemic Stroke

Interventions: Device: Mechanical Thrombectomy

Registration Number: NCT01270867

Lead Sponsor: Stryker Neurovascular

Brief Summary: 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: 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."

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 178

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Merci Retriever	Mechanical Thrombectomy	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.
Trevo Stentriever	Mechanical Thrombectomy	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.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint	acute/procedural	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\[PubMed\]
Primary Safety Endpoint	within 24 hours of procedure	Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).