Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year
研究概览
简要总结
The objective of this study was to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke/transient ischemic attack with intracranial atherosclerosis etiology.
详细描述
In this study, 416 patients with minor strokes or transient ischemic attacks due to symptomatic intracranial atherosclerotic stenosis within one week of the onset of last ischemic symptoms from 20 centers in China were enrolled. The observation group received early submaximal balloon angioplasty, while the control group received only medical therapy. Two groups will be followed up for 1 year to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke / transient ischemic attack with intracranial atherosclerosis etiology.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range of 30-80 years;
- •symptomatic ICAS (C4-C7 segments of ICA, M1 segment of the MCA, V4 segment of the VA, and BA) with 70%-99% stenosis confirmed by DSA;
- •minor stroke (NIHSS score ≤5) within 1 week of onset or from symptom exacerbation (NIHSS score increased by ≥2 points) or intermediate- to high-risk TIA, defined as ABCD2 score ≥4 within 1 week of the last symptom episode;
- •diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;
- •mRS ≤ 2 before endovascular treatment；
- •no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8)；
- •written informed consent obtained from the patient or legally responsible person.
排除标准
- •allergy to contrast media;
- •non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
- •penetrating branch lesion ipsilateral to the target lesion (infarction caused by penetrating branch occlusion is defined as stenosis of the MCA or BA, but only with simple basal ganglia or brainstem/thalamic infarction);
- •presence of severe stenosis of the extracranial segment on the side of the target lesion;
- •previous endovascular treatment of the ipsilateral vessel;
- •presence of intracranial aneurysms, tumors, and vascular malformations;
- •any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks;
- •presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year;
- •hemoglobin ≤ 100g/L, platelet count ≤ 100×10^9/L, INR> 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
- •uncontrollable hypertension: systolic blood pressure >185 mmHg and/or diastolic blood pressure >110 mmHg;
- •poor glycemic control (random blood glucose > 22.2 mmol/L);
- •history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
- •pregnancy or lactation;
- •other conditions that the researchers think make the patient unsuitable for the study.
结局指标
主要结局
Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year
时间窗: 30 days, 1 year
Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year
次要结局
- Stroke or death within 30 days after enrollment(30 days)
- Evaluation of neurological function improvement within 90 days of enrollment(90 days)
- Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment(1 year)
- Restenosis rate of criminal artery within 1 year after enrollment(1 year)
研究者
Shouchun Wang, MD, PhD
Chief physician of the Department of Neurology
The First Hospital of Jilin University