Rapamycin-eluting Vertebral Stents in the Real-world Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
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%).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
zhangyong
Chief Physician, Department of Neurointerventional Medicine, The Affiliated Hospital of Qingdao University
The Affiliated Hospital of Qingdao University