Clinical Outcome of Balloon-Expandable Drug-Eluting Stenting For Patients With Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Real-World Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 520
- 主要终点
- Any stroke or death within 30 days of implantation or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
研究概览
简要总结
To study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.
详细描述
This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •According to clinical and angiographic evidence, symptomatic intracranial arteries stenosis within 3 months include vertebral artery V4 segment or internal carotid artery C2-C7 segment, and the degree of diseased arterial stenosis is between 70%~99% (WASID method).
- •Patients have more than 1 episode of symptoms including stroke or transient ischemia attack (TIA) after intensive medical treatment (including antiplatelet therapy, antihypertensive, hypoglycemic and lipid-lowering treatments).
- •Patients have at least 1 risk factor for intracranial atherosclerosis, including previous or existing hypertension, hyperlipidemia, diabetes mellitus, smoking, alcohol consumption, obesity, underlying heart disease, family history of atherosclerotic vascular disease, hyperhomocysteinemia and so on.
- •Baseline mRS score ≤
- •Patient or guardian signs informed consent.
排除标准
- •Patients who cannot receive dual antiplatelet therapy due to existing diseases or with server coagulation dysfunction, uncontrolled serious infections, serious systemic diseases, uncontrollable hypertension and other conditions are not suitable for surgery.
- •Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
- •Gastrointestinal disease with active bleeding.
- •Myocardial infarction or massive cerebral infarction within 2 weeks.
- •Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.
- •Life expectancy <12 months.
- •According to the judgement of the investigator, other situations that are not suitable for enrollment.
结局指标
主要结局
Any stroke or death within 30 days of implantation or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
时间窗: 12 months after implantation
Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year.
次要结局
- Any cerebral events within 1 year(12 months after implantation)
- Periprocedural events(within 30 days after implantation)
- In-stent restenosis(ISR) rate(12 months after implantation)
- Technique success rate(During the procedure)
- Functional outcome measured by modified Rankin Scale and NIH stroke scale (NIHSS) score(Every year after implantation during 5 years)