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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-03-31

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.

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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."

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Merci Retriever

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.

Group Type ACTIVE_COMPARATOR

Mechanical Thrombectomy

Intervention Type DEVICE

Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.

Trevo Stentriever

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.

Group Type EXPERIMENTAL

Mechanical Thrombectomy

Intervention Type DEVICE

Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.

Interventions

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Mechanical Thrombectomy

Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No