Trial record 2 of 4 for:    trevo

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

This study has been completed.
Information provided by (Responsible Party):
Stryker Neurovascular Identifier:
First received: January 4, 2011
Last updated: January 9, 2014
Last verified: December 2013

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 Intervention
Ischemic Stroke
Device: Mechanical Embolectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)

Resource links provided by NLM:

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Primary Efficacy Endpoint [ Time Frame: acute/procedural ] [ Designated as safety issue: No ]
    Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device.

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

Secondary Outcome Measures:
  • Secondary Endpoint [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Good clinical outcomes at 90 days, as assessed by mRS (a "good" clinical outcome is defined as mRS </= 2)

  • Secondary Endpoint [ Time Frame: procedure through 90 days ] [ Designated as safety issue: Yes ]
    All cause mortality at 90 days

  • Secondary Endpoint [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure

Enrollment: 178
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Merci Retriever Device: Mechanical Embolectomy
Each arm will use either Merci or Trevo as the primary embolectomy device.
Experimental: Trevo Stentriever Device: Mechanical Embolectomy
Each arm will use either Merci or Trevo as the primary embolectomy device.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT01270867

United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States
Sponsors and Collaborators
Stryker Neurovascular
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

Additional Information:
Responsible Party: Stryker Neurovascular Identifier: NCT01270867     History of Changes
Other Study ID Numbers: DQR0038
Study First Received: January 4, 2011
Results First Received: November 20, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Neurovascular:
Ischemic Stroke
Mechanical Thrombectomy
Brain clot
Cerebrovascular disease

Additional relevant MeSH terms:
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia processed this record on April 17, 2014