Comparing Drug-Eluting Stent Plus Aggressive Medical Treatment Versus Standard Treatment to Prevent Stroke Recurrence in Intracranial Artery Narrowing

What this Trial Is About

Researchers are studying whether using a drug-eluting stent DES combined with aggressive medical treatment is more effective at preventing stroke recurrence within one year compared to standard medical treatment alone in patients with symptomatic intracranial atherosclerotic disease. This prospective, multi-center trial randomly assigns participants to either the stent plus aggressive medication group or the standard treatment group to evaluate safety and stroke prevention outcomes. The study compares two groups one receiving the Maurora Sirolimus Eluting Stent implantation plus aggressive medical treatment, which includes aspirin daily throughout follow-up, clopidogrel or ticagrelor for six months, and management of risk factors like hypertension and diabetes the other receiving standard medical treatment with aspirin daily, clopidogrel or ticagrelor for three months, and similar risk factor management. The device used is a balloon-expandable sirolimus-eluting stent delivered via catheter. Follow-up lasts 12 months after enrollment. Participants will undergo regular assessments including monitoring for stroke or death within 30 days after enrollment or procedures, ischemic stroke occurrence up to one year, bleeding events, imaging to check for vessel narrowing, and functional status evaluations. Safety and effectiveness are closely tracked through clinical visits and tests over the 12-month period. The study aims to provide detailed data on stroke recurrence prevention and treatment safety in this patient population.

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial