NCT06437600招募中不适用
Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University2 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2025年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 412
- 试验地点
- 2
- 主要终点
- The modified Rankin Scale (mRS) 0-2
研究概览
简要总结
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.
详细描述
This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2.
Study intervention: (1) Participants in the intervention group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMT) after the procedure. (2) Participants in the control group will receive BMT alone.
This study is anticipated to enroll 412 participants.
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
- •Aged 18 years or older.
- •Diagnosed with AIS and baseline NIHSS ≥
- •Pre-stroke mRS ≤
- •Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
- •Non-contrast CT ASPECTS score ≥
- •CTA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke.
- •Informed consent signed by the patient or authorized representative.
排除标准
- •Normal diameter of the culprit vessel <2.0 mm.
- •Isolated perforator artery infarction (except for combined cortical hypoperfusion).
- •Hemorrhagic stroke within the past 90 days.
- •Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
- •Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
- •Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
- •INR >1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
- •Platelet count <50×10^9/L.
- •Intracranial hemorrhage confirmed by CT or MRI.
- •Women who are pregnant or breastfeeding.
- •Participation in other intervention clinical trials.
- •Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl).
- •Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
- •Aortic dissection.
- •Concomitant intracranial tumor (except for meningioma <10mm) or arteriovenous malformation.
- •Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
- •Any active bleeding or recent bleeding in the last 1 month.
- •SBP>185 mmHg or DBP>110 mmHg refractory to treatment.
- •Anticipated life expectancy <3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
- •Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
结局指标
主要结局
The modified Rankin Scale (mRS) 0-2
时间窗: 90(±7) days
The proportion of the mRS 0-2 at 90 days.
次要结局
- The mRS 0-1(90(±7) days)
- The mRS 0-3(90(±7) days)
- The shift analysis of the mRS distribution(90(±7) days)
- The change of National Institute of Health Stroke Scale (NIHSS)(7(±1) days or discharge, whichever came first)
- The quality of life(90(±7) days)
- Any new stroke (ischemic/hemorrhagic) or all-cause mortality(within 30 days)
- Any recurrent stroke in the territory of the target artery(within 90 days)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical ThrombectomyICAS - Intracranial AtherosclerosisStrokeAISNCT06702657Changhai Hospital612
已完成
3 期
Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical ThrombectomyStroke, Acute IschemicNCT05856851Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University324
已完成
不适用
Basilar Artery Occlusion Chinese Endovascular TrialBasilar Artery OcclusionIschemic StrokeCerebrovascular DisordersNCT02737189Xuanwu Hospital, Beijing217
撤回
2 期
Endovascular Stroke Treatment And Reteplase ProtocolIschemic StrokeNCT05900674Zeenat Qureshi Stroke Institute
已完成
2 期
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical TrialIschemic StrokeNCT01678534Instituto de Investigación Hospital Universitario La Paz19