Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

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.

• Clinical outcomes at 90 days
• Mortality at 90 days
• Device-related serious adverse events (DRSAEs)
• Symptomatic ICH rate within 24 (-6/+12) hours post-procedure

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