Brain Diseases, Intracranial Arterial Stenosis
Conditions
Brief summary
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%).
Interventions
None listed
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * Severe dysfunction of major organs (e.g., severe hepatic insufficiency, renal insufficiency, heart failure); * Severe allergies to contrast agents, rapamycin and its derivatives, cobalt-based alloys, or polylactic acid; * Pregnant or lactating women; * Participation in other drug or device studies without reaching the endpoint; * Life expectancy less than 12 months; * Lesions or vascular access deemed unsuitable for rapamycin drug-eluting stent implantation by the operator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of any stroke or death within 1 month after the procedure | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | 1 year | mRS≥2 |
Countries
China
Contacts
CONTACTYong Zhang
Outcome results
None listed