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


Phase 4 Results

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