Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year
研究概览
简要总结
This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe intracranial stenosis.
详细描述
The study will enroll 200 Chinese patients with atherosclerotic intracranial stenosis of 70% to 99% that causes a recent ischemic neurologic event.
The Winspan stenting following undersized Gateway balloon angioplasty will be performed at experienced centers (at least 10 cases' experiences of using the Wingspan system to treat the patients with intracranial stenosis for each center).
The primary endpoint of the study, independently evaluated by neurologists, is any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An angiographically verified ≥ 70% stenosis of a major intracranial artery that causes TIA or minor stroke (NIH Stroke Scale score <9) within 90 days;
- •the lesion length <15 mm and normal arterial diameter adjacent to it between 2.0 mm and 4.5 mm;
- •patients having at least one atherosclerotic risk factor (arterial hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia and cigarette smoking).
排除标准
- •Non-atherosclerotic stenosis;
- •intracranial hemorrhage in the territory of the stenotic artery within 6 weeks; potential source of cardiac embolism;
- •concurrent intracranial tumor, aneurysm and cerebral arteriovenous malformation;
- •tandem >50% stenosis of extracranial carotid or vertebral artery; known contraindication to heparin, aspirin, clopidogrel, anesthesia and contrast media; hemoglobin <10 g/dl, platelet count <100,000;
- •international normalized ratio >1.5 (irreversible) and uncorrectable bleeding diathesis; and life expectancy <1 years because of other medical conditions.
结局指标
主要结局
Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year
时间窗: One year
次要结局
- Ischemic stroke in the non-stented artery territory, hemorrhagic stroke and death from other vascular causes beyond 30 days, and emergent cerebral revascularization (ECER)and other major hemorrhages at any time within 1 year, and restenosis.(One year)