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%).
Study Type
OBSERVATIONAL
Enrollment
300
Qingdao University Affiliated Hospital
Qingdao, Shandong, China
RECRUITINGIncidence of any stroke or death within 1 month after the procedure
Time frame: 1 month
Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup)
Time frame: 1 year
Immediate techenical success rate of stent implantation (imaging subgroup)
Time frame: immediately after the intervention
Incidence of stroke or neurogenic death within 1-year follow-up
Time frame: 1 year
Incidence of target vessel-related stroke or death within 1-year follow-up
Time frame: 1 year
All-cause mortality within 1-year follow-up
Time frame: 1 year
mRS score at 1-year follow-up
mRS≥2
Time frame: 1 year
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