A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic Stroke System (ISS), as an Adjunct to Standard of Care in Subjects with Mild Acute Ischemic Stroke~Study Duration:~The expected total duration of the study for each subject is up to 10 days as follows:~Enrollment: up to 24 hours Treatment: Implantation, 5 Days of SPG stimulation and Standard of care Final Visit: 7 days after enrollment~Study Population:~Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.~Study Objectives:~Identify the personal stimulation level for each patient based on physiological biomarkers~Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level~Study Design:~This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps:~Screening (day 1)~Implantation (day 1)~Treatment and symptom assessment (days 1-5)~Device Positioning and Removal (day 5)~Discharge/Final Visit (day 7-10)~Outcome Measures:~Primary Outcome Measures:~The difference in NIHSS between baseline and Day 7 vs. Historical Controls~% of patients with improvement in stroke symptoms (motor and/or sensory deficits) during stimulation~Additional Efficacy Outcome Measures:~Existence of physiologic surrogates of the Personal Stimulation Level~Improvement in stroke symptoms (motor and/or sensory deficits)~Safety Outcome Measures:~Comparative 7-day safety data between the ISS stimulation group of this study and of the ImpACT-24B study:~Incidence of Serious Adverse Events~Implantation Complications~Stimulation-related Adverse Events~7-day mortality~Neurological deterioration~Symptomatic intracranial hemorrhage (sICH)~Implantation Accuracy Outcome Measures:~1. % of procedures with positive indication of reaching the sphenopalatine fossa
Study Population:~Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.~Study objectives:~Identify the personal stimulation level for each patient based on physiological biomarkers~Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level