NCT06763458招募中不适用
Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)
研究概览
简要总结
Intracranial atherosclerotic stenosis (ICAS) is a common cause of stroke, especially in East and South Asia, and is significantly associated with stroke recurrence and early neurological deterioration (END) despite aggressive medical management. Minor stroke (National Institutes of Health Stroke, NIHSS score ≤ 5) patients with ICAS often has higher risk of END. The early realization of blood flow patency is closely related to the improvement of patient outcomes. Submaximal balloon angioplasty (SBA) as a safer and simpler intervention which can improve cerebral blood flow. Thus, SBA may be an effective strategy for preventing END in acute ischemic stroke patients with ICAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Over 18 years of age;
- •Minor ischemic stroke within 1 week of onset (NIHSS≤5);
- •Have received the best drug treatment (dual antibody, anti-plate combined with anticoagulation), but symptoms still have measurable fluctuations or progression (NIHSS increased by at least 1 point);
- •Symptoms fluctuate to the time of receiving balloon dilation within 24 hours;
- •The etiology was considered to be severe stenosis of the responsible vessels due to intracranial arteriosclerosis (70-99% stenosis), or perforator artery disease with severe stenosis of the carrier artery (confirmed by MRA, CTA or DSA);
- •Patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points;
- •Patients or family members sign informed consent.
排除标准
- •Patients who have developed large intracranial vessel occlusion;
- •Intracranial hemorrhagic diseases in the past 3 months: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
- •Non-atherosclerotic disease-related stenosis: arterial dissection, moya-moya disease, arterioinflammatory disease, etc.
- •Clotting disorders or systemic bleeding tendency or platelets less than 100,000;
- •Complicated with serious infection or liver, kidney and other serious diseases;
- •Patients with severe inability to control hypertension (systolic blood pressure >200mmHg or diastolic blood pressure >110mmHg);
- •Women who are pregnant, have a pregnancy plan or are breastfeeding;
- •Complicated with other serious diseases, life expectancy < 6 months; Other conditions deemed inappropriate for participation in this study.
研究组 & 干预措施
SBA group
Experimental
Receiving SBA plus best medical therapy
干预措施: Submaximal balloon angioplasty (Procedure)
Control group
No Intervention
Receiving best medical therapy
结局指标
主要结局
Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)
时间窗: at 24±8 hours
次要结局
- The decrease of NIHSS score(at 10±2 days)
- Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)(at 24±8 hours)
- Proportion of patients with modified Rankin Score 0 to 1(at 90±7 days)
- Proportion of patients with modified Rankin Score 0 to 2(at 90±7 days)
- Distribution of patients with modified Rankin Score(at 90±7 days)
- the occurence of stroke or other cardiovascular events(at 90±7 days)
- ischemic stroke in the culprit artery territory(at 90±7 days)
- Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria)(at 24±8 hours)
- Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)(at 24±8 hours)
- Proportion of serious adverse events(at 24±8 hours)
- Proportion of all-cause deaths(at 10±2 days)
- Complications associated with endovascular therapy(at 24±8 hours, at 10±2 days, at 90±7 days)
- The decrease of NIHSS score(at 24±8 hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
The New Clinical Registration Trial of Interventional Treatment for Patients with Symptomatic Intracranial Artery StenosisIntracranial Atherosclerotic Stenosis (ICAS)StrokeNCT06740513Xuanwu Hospital, Beijing1,000
Unknown
4 期
A Randomized Double Blind Placebo Control Study of Huang-Chi-Wu-Wu- Tang in Patients With Intracranial Arterial StenosisIntracranial Arterial StenosisNCT01553643China Medical University Hospital80
已完成
3 期
China Angioplasty & Stenting for Symptomatic Intracranial Severe StenosisIschemic StrokeNCT01763320Xuanwu Hospital, Beijing380
Enrolling By Invitation
不适用
Angiogenic Markers in Cerebrovascular Disease (ANFIS)Intracranial Arterial StenosisMoyamoyaStrokeAtherosclerosisTransient Ischemic AttackNCT04240119Cedars-Sinai Medical Center300
招募中
3 期
Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic StrokeStroke, Acute IschemicNCT06768138Central Hospital, Nancy, France626