NCT07336927尚未招募不适用
Efficacy and Safety of Endovascular Therapy With Intra-Arterial Thrombolysis for Medium Vessel Occlusion Stroke--the IAT-MeVO Trial
Bo Wu1 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2026年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- Excellent functional outcome
研究概览
简要总结
IAT-MeVO is an international, multicenter, prospective, randomised, open-label, blinded end-point assessed (PROBE) trial, to evaluate the efficacy and safety of endovascular therapy (EVT) [intra-arterial thrombolysis (IAT)-based] versus best medical management (BMT) in patients with acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) who are ineligible for intravenous thrombolysis (IV) within 24 h of onset.
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)
盲法说明
Open-label trial; only the outcome assessors and partial data analysts will be masked to treatment allocation
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 y;
- •Diagnosed as acute ischemic stroke;
- •Isolated medium distal vessel occlusion (i.e. an occlusion of the M2, the M3/M4 segment of the MCA, the A1/ A2/A3 segment of the ACA or the P1/P2/P3 segment of the PCA) confirmed by CT or MR Angiography;
- •Time from onset (or last-seen-well) to randomization < 24h;
- •Has not received intravenous thrombolysis and is considered unsuitable for it based on the treating clinician's assessment.
- •NIHSS ≥ 5, or NIHSS ≤ 4 with disabling deficit (e.g. severe aphasia, hemianopia, hemiplegia/loss of function in one side) or fluctuating symptoms at the time of randomization;
- •For patients within 6 h of onset: No visually apparent hypodensity is observed on non-contrast CT compared with the contralateral white matter, or no hyperintensity is seen on fluid-attenuated inversion recovery (FLAIR) imaging; For patients presenting 6-24 h after onset: A perfusion imaging-based ischemic core mismatch ratio >1.2 and an infarct core volume <50 mL are required;
- •Pre-stroke mRS ≤ 1；
- •Patient/Legally Authorized Representative has signed the Informed Consent form.
排除标准
- •Any evidence of intracranial hemorrhage on qualifying imaging;
- •Concurrent multiple (≥2) intracranial arterial occlusions;
- •Suspected cerebral vasculitis, septic embolism, or infective endocarditis as the cause of vessel occlusion;
- •Suspected arterial dissection;
- •Clinical assessment of conditions unsuitable for interventional therapy (e.g., severe contrast agent allergy or absolute contraindications to iodine contrast agent; severe renal insufficiency, glomerular filtration rate < 30ml/min or serum creatinine > 220μmol/L (2.5 mg/dl));
- •Unsuitable for arterial thrombolytic therapy (e.g., known history of hereditary or acquired hemorrhagic disease and/or platelet count <50×109/L; abnormal coagulation function (INR>1.7); oral anticoagulants were taken within 24 - 48 hours before onset within APTT > 3 times normal; recent medical history or clinical manifestations of brain tumors other than meningiomas);
- •Any terminal disease with life expectancy <1 year;
- •Pregnancy or lactation;
- •Concurrent participation in another investigational drug or device study that could interfere with the present trial;
- •Other circumstances that participation is not deemed appropriate.
结局指标
主要结局
Excellent functional outcome
时间窗: 90 days
The proportion of patients with an mRS score of 0-1.
次要结局
- Final infarct volume(24-72 hours)
- Symptomatic intracranial hemorrhage (sICH)(7 days)
- Malignant cerebral edema(7 days)
- All-cause mortality(90 days)
- EVT-related adverse events(4 days)
- Good functional outcome(90 days)
- Distribution of functional outcome(90 days)
- Health-related quality of life (HRQoL)(90 days)
- Neurological status(72±12 hours)
- Early neurological improvement(72±12 hours)
- Any intracranial hemorrhage(7 days)
- All-cause mortality(7 days)
研究者
Bo Wu
Dr.
West China Hospital
研究点 (1)
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