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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT01270867
First received: January 4, 2011
Last updated: January 9, 2014
Last verified: December 2013
  Purpose

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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270867

Locations
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov 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:
Ischemia
Stroke
Ischemic Stroke
Mechanical Thrombectomy
Brain
Brain clot
Cerebrovascular disease
Recanalization
Revascularization

Additional relevant MeSH terms:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014