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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exposed group | subjects undergoing rapamycin-eluting stent implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any stroke or death within 1 month after the procedure | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup) | 1 year | |
| Immediate techenical success rate of stent implantation (imaging subgroup) | immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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subjects undergoing rapamycin-eluting stent implantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Zhang | Contact | (+86) 18661818866 | bravezhang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao University Affiliated Hospital | Recruiting | Qingdao | Shandong | China |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Incidence of stroke or neurogenic death within 1-year follow-up | 1 year |
| Incidence of target vessel-related stroke or death within 1-year follow-up | 1 year |
| All-cause mortality within 1-year follow-up | 1 year |
| mRS score at 1-year follow-up | mRS≥2 | 1 year |