Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial (GRASSROOT)
The study aims to evaluate the safety and efficacy of the Supernova stent retriever device, developed by Gravity Medical Technology, for treating acute ischemic stroke. The device is used to remove blood clots and restore blood flow to the brain .
• New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
• Age 18-85 years old (inclusive).
• Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset.
• Intravenous thrombolysis may be given as per national guidelines and patients receiving or not receiving intravenous thrombolysis will both be eligible for inclusion in the study.
• Admission NIH Stroke Scale score of 8-25
• No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
• Catheter angiographic confirmation of large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, or the basilar artery that is accessible to the Supernova device.
• For strokes in the anterior circulation, the following imaging criteria should also be met:
∙ MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
‣ CT criterion: ASPECTS 6 to 10 on baseline NCCT
• Anticipated life expectancy of at least 6 months.
⁃ A signed informed consent by the patient or a Legally Authorized Representative or independent physician in case of oral consent.