Rapamycin-eluting Vertebral Stents in the Real-world Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
This clinical trial is a prospective, multicenter, single-arm study. About 300 subjects undergoing rapamycin-eluting stent implantation will be enrolled based on the inclusion and exclusion criteria. The primary endpoint is the rate of any stroke or death within 1 month. Secondary efficacy endpoints include immediate stent implantation success. Safety endpoints cover the incidence of stroke or neurological death, target-vessel-related stroke or death, all-cause mortality, and mRS scores at 12-month follow-ups. Subjects will be clinically followed up before surgery, device implantation, discharge, and at 1, 6, and 12 months post-surgery. An imaging subgroup of at least 80 subjects who agree to DSA follow-up at 12 months will assess in-stent restenosis (\>50%).
• Age ≥18 and ≤80 years;
• Symptomatic intracranial atherosclerotic stenosis patients with ineffective medical treatment;
• Digital subtraction angiography (DSA) shows target lesion stenosis ≥70%;
• Suitable for implantation of rapamycin-targeted drug-eluting stents;
• The patient and/or their authorized representative can understand the study purpose, agree to participate, and sign the informed consent form.