NCT06702657尚未招募不适用
A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy (ICAS LVO-MT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 612
- 主要终点
- Functional recovery
研究概览
简要总结
A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial
详细描述
The main objective of AIS ICAS-MT study is to evaluate whether direct stenting, compared with medical therapy can benefit patients with acute ischemic stroke caused by CTA-confirmed large vessel occlusion (intracranial segments ICA, M1, BA, V4) who have been successfully recanalized by mechanical thrombectomy (MT) and are judged to be in situ ICAS lesions.
Primary outcomes: Functional recovery, defined as a sequence shift (improvement) in scores on the mRS at 90 (±14) days.
Secondary outcomes:
- Rate of good functional outcome (mRS of 0-2) at 90±14 days
- Rate of excellent functional outcome (mRS of 0-1) at 90±14 days
- Change in stroke severity (NIHSS score) at 24±12 hours
- Change in stroke severity (NIHSS score) at 7±2 days or discharge
- Proportion of target vessel recanalisation (eTICI≥2b) at 5±2 days confirmed by CTA
- Final infarct volume at 5±2 days
- EuroQol Five Dimensions (EQ-5D) Score at 90±14 days
- Barthel Index at 90±14 days
- mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
- Stroke between 90 days and 365 days
- mRS Score shift at 365±30 days as an ordinal variable
- Rate of good functional outcome (mRS of 0-2) at 365±30 days
- Rate of excellent functional outcome (mRS of 0-1) at 365±30 days
- EuroQol Five Dimensions (EQ-5D) Score at 365±30 days
- Barthel Index at 365±30 days
Safety outcomes:
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
- •Clinical inclusion criteria:
- •Age ≥ 18 years
- •National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
- •To receive mechanical thrombectomy <24 hours after AIS onset according to local guidelines
- •Signed informed consent form obtained from the subject (or approved surrogate)
- •Imaging inclusion criteria:
- •For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
- •For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) < 3 based on CT or DWI
- •Angiography inclusion criteria:
- •The responsible occluded vessel is immediately recanalized (eTICI≥2b) after mechanical thrombectomy, ICAS is highly suspected and the focal residual stenosis of the main trunk is≥70%, and the responsible occluded vessels include the intracranial segment of the internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, and the basilar artery
- •According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty
排除标准
- •Pre-stroke mRS >2
- •Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
- •Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
- •Tandem lesions: stenosis (or occlusion) of the extracranial segment of the internal carotid artery or vertebral artery combined with occlusion of large intracranial vessels, stenosis of intracranial arteries combined with occlusion of vessels distal to the stenosis
- •More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
- •Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
- •Current use of oral anticoagulants
- •Major surgery or serious trauma in the previous 2 weeks
- •Contraindication for mechanical thrombectomy or stenting angioplasty
- •Contraindication for antiplatelet treatment or allergy to contrast agent
- •History of gastrointestinal or urinary bleeding in the previous 3 weeks
- •Life expectancy less than 1 years
- •Current pregnant or breastfeeding status
- •Currently participating in another clinical trial that may affect the outcome assessment of this trial
- •Any other condition that, in the investigator's judgement, deems the individual unsuitable for enrolment.
研究组 & 干预措施
Control group
Active Comparator
干预措施: medication (Drug)
Intervention group
Experimental
干预措施: balloon dilatation and/or stenting (Device)
结局指标
主要结局
Functional recovery
时间窗: 90(±14) days
defined as a sequence shift (improvement) in scores on the mRS
次要结局
- Rate of good functional outcome(365 (±30) days)
- Rate of excellent functional outcome(365 (±30) days)
- Change in stroke severity (NIHSS score)(7±2 days or discharge)
- Proportion of target vessel recanalisation (eTICI≥2b)(5±2 days)
- Final infarct volume(5±2 days)
- EuroQol Five Dimensions (EQ-5D) Score(365 (±30) days)
- Barthel Index(365 (±30) days)
- mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days(365days)
- Stroke(between 90 days and 365 days)
- mRS Score shift(365 (±30)days)
研究者
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