Stroke, Acute Cerebral Infarction Clinical Trial
Official title:
Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy
This study aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular thrombectomy initiated between 6-24 hours after last seen well.
Study design is a prospective, single-center study of acute ischemic stroke patients with large artery occlusion in 6-24 hours of stroke onset. According to patients or their family members' willing, patients who meet the inclusion criteria will be assigned to endovascular thrombectomy group with approved devices (only the devices listed in this protocol are approved for us) plus standard medical therapy or control group (standard medical therapy alone) after undergoing either CT Perfusion or MR Perfusion studies. Patients who have evidence of an ICA or MCA M1 or M2 or BA occlusion and a Target Mismatch Profile will be enrolled. The intent of this study is to support thrombectomy beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms, with careful selection. The study will enroll up to 55 patients. The primary endpoint, the modified Rankin Score, will be assessed at 3 months. ;