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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):
Concentric Medical
ClinicalTrials.gov Identifier:
NCT01270867
First received: January 4, 2011
Last updated: October 23, 2012
Last verified: October 2012
History of Changes

January 4, 2011
October 23, 2012
February 2011
December 2011   (final data collection date for primary outcome measure)
  • 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).
Not Provided
Complete list of historical versions of study NCT01270867 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke
Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
Device: Mechanical Embolectomy
Each arm will use either Merci or Trevo as the primary embolectomy device.
  • Active Comparator: Merci Retriever
    Intervention: Device: Mechanical Embolectomy
  • Experimental: Trevo Stentriever
    Intervention: Device: Mechanical Embolectomy
Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
March 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01270867
DQR0038
Yes
Concentric Medical
Concentric Medical
Not Provided
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
Concentric Medical
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP