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Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2)

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ClinicalTrials.gov Identifier: NCT01270867
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : February 27, 2014
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Mechanical Thrombectomy Not Applicable

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."

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)
Study Start Date : February 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: Mechanical Thrombectomy
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.
Experimental: 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.
 Device: Mechanical Thrombectomy
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Efficacy Endpoint [ Time Frame: 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]


  2. Primary Safety Endpoint [ Time Frame: within 24 hours of procedure ]
    Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).


Secondary Outcome Measures :
  1. Secondary Endpoint [ Time Frame: 90 days ]

    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.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Sca

  2. Secondary Endpoint [ Time Frame: procedure through 90 days ]
    All cause mortality at 90 days

  3. Secondary Endpoint [ Time Frame: 24 hours ]
    Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270867


Locations
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United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Raul G Nogueira, MD Emory University
Principal Investigator: Helmi Lutsep, MD Oregon Health and Science University
Principal Investigator: Wade Smith, MD, PhD University of California, San Francisco
More Information
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Additional Information:
Concentric Medical Website  This link exits the ClinicalTrials.gov site American Stroke Association  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01270867     History of Changes
Other Study ID Numbers: DQR0038
First Posted: January 5, 2011    Key Record Dates
Results First Posted: February 27, 2014
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by Stryker Neurovascular:
Ischemia
Stroke
Ischemic Stroke
Mechanical Thrombectomy
Brain
 Brain clot
Cerebrovascular disease
Recanalization
Revascularization
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia