Intra-arterial Neuroprotective Strategy for Ischemic Stroke Patients Without Reperfusion Therapy: Safety and Feasibility Study

What this Trial Is About

Researchers are evaluating the safety and feasibility of an intra-arterial neuroprotective strategy for patients who have acute ischemic stroke but missed recanalization treatment. This study focuses on patients with major neurological deficits and progressive stroke symptoms within 48 hours. The goal is to explore a treatment option that could potentially help those who did not receive standard reperfusion therapies. The study involves delivering 3-n-butylphthalide directly into an artery through a microcatheter for 24 hours at a rate of 17.36 micrograms per minute. This intra-arterial administration is the experimental treatment being assessed. There are no placebo or comparison arms mentioned, and the treatment is given as a single intervention during the study period. Participants will be monitored for severe adverse events within the first 48 hours after treatment, which is the primary outcome measure. Secondary outcomes include assessments of neurological function using the National Institutes of Health Stroke Scale, modified Rankin Score for disability at 90 days, intracranial hemorrhage incidents, cerebral edema changes, and death causes within 48 hours. Blood serum factors will also be evaluated at the start. Overall, participant involvement includes treatment administration and follow-up evaluations up to 90 days for functional outcomes and safety monitoring.

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)