Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: Mechanical Thrombectomy
Intervention description: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Stroke; Ischemic; Thrombus; Embolectomy; Thrombectomy; Concentric; Embolus; Mechanical; Trevo

Summary:

      To determine the revascularization rate of the CE-marked Trevo device in large vessel
      occlusions in ischemic stroke patients.

        -  Revascularization, defined as at least TICI 2a in the vascular territory treated at end
           of the neuro interventional procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-79 (has had 18th birthday, but not yet had 80th birthday)

          -  NIHSS 8 - 30

          -  Anticipated life expectancy of at least 6 months

          -  No significant pre-stroke disability (mRS less than or equal to 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 or vertebral arteries

          -  Treatable within 8 hours of symptom onset, defined as the first pass being made with
             the Trevo device.

        Exclusion Criteria:

          -  Baseline glucose of < 50 mg/dL (2.78 mmol) or > 400 mg / dL (22.20 mmol)

          -  Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant
             therapy with INR > 3.0

          -  Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal

          -  Baseline platelet count < 30,000

          -  History of severe allergy (more than rash) to contrast medium

          -  Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood
             pressure can be successfully reduced and maintained at the acceptable level using
             medication (i.e. Nipride), the patient can be enrolled

          -  Woman of child bearing potential who is known to be pregnant

          -  Patient participating in another clinical study or protocol

          -  For anterior circulation strokes: strokes involving greater than 1/3 of the MCA
             territory, as determined by hypodensity on the baseline non- contrast CT, or low CBV
             on CT Perfusion imaging, or restricted diffusion on DWI images

          -  For posterior circulation strokes within the midbrain and/or pons, extensive
             hypodensity on the baseline CT, or low CBV on CT Perfusion imaging, or extensive
             restricted diffusion on DWI images

          -  Baseline CT/MR evidence of significant mass effect with midline shift

          -  Baseline CT/MR evidence of hemorrhage

          -  Baseline CT/MR evidence of intracranial tumor (except small meningioma)

          -  Angiographic evidence of vasculitis or arterial dissection

          -  High grade stenosis that cannot be treated safely or which prevents access to the
             thrombus with the Trevo device

          -  Angiographic evidence of excessive arterial tortuosity that precludes the Trevo device
             from reaching the thrombus