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;
Modified Rankin Scale (mRS) score ≥3;
Ischemic stroke within the past 2 weeks;
Presence of more than 2 intracranial atherosclerotic stenosis lesions requiring interventional treatment;
Severe contraindications to heparin, aspirin, ticagrelor, clopidogrel, or other antiplatelet drugs, and inability to tolerate anticoagulant/antiplatelet therapy;
subjects undergoing rapamycin-eluting stent implantation
Cohort
Prospective
Not listed
Incidence of any stroke or death within 1 month after the procedure
Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup)
Immediate techenical success rate of stent implantation (imaging subgroup)
Incidence of stroke or neurogenic death within 1-year follow-up
Incidence of target vessel-related stroke or death within 1-year follow-up
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