Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
研究概览
简要总结
Endovascular thrombectomy (EVT) has become the standard of care for large vessel occlusion in acute ischaemic stroke (AIS). During clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation to new vascular territories. Retrospective studies indicate that this may improve complete vessel recanalisation rates and may translate to improved functional independence. However, lack of high-quality evidence demonstrating the efficacy of simultaneous balloon inflation has led to clinical equipoise with heterogeneity of practice globally.
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
- Double (Participant, 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
- •Age ≥18 years
- •Acute ischemic stroke presenting with a neurological deficit of (NIHSS ≥2)
- •Intracranial arterial occlusion of the distal internal carotid artery or middle cerebral artery (M1/M2 segments) demonstrated with on clinical neuroimaging such as: computed tomography angiogram (CTA), magnetic resonance imaging angiogram (MRA), or digital subtraction angiography (DSA).
- •ASPECTS score of >4 or by locally accepted ischaemic core/penumbra mismatch using computed tomography perfusion or magnetic resonance (CTP or MR) imaging.
- •modified Rankin Scale, mRS<3
- •Intention to treat with aspiration only or combination technique of stent-retriever + aspiration in the first pass attempt during endovascular thrombectomy
排除标准
- •Severe stenosis (>90%), or tandem occlusion of the ipsilateral extracranial internal carotid artery.
- •Previously deployed stents in the ipsilateral internal carotid artery.
- •Dissections of the ipsilateral internal carotid artery.
- •Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- •Subject participating in a study involving an investigational drug or device that would impact this study.
结局指标
主要结局
Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
时间窗: Immediately after endovascular thrombectomy
Near complete-complete vessel recanalisation
次要结局
- Symptomatic intracranial haemorrhage(24 hours after Endovascular thrombectomy)
- Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3(Immediately after endovascular thrombectomy)
- Mortality(90 days)
- New or distal vascular territory clot embolisation(Immediately after endovascular thrombectomy)
- National Institutes of Health of Stroke Scale (NIHSS)(24 hours)
- First pass effect (mTICI2c-3)(During endovascular thrombectomy procedure)
- Modified Rankin Scale 0-2(90 days)
- Total number of passes at clot retrieval(Immediately after endovascular thrombectomy)
- Procedure related complications(Immediately after endovascular thrombectomy)
- Total procedural time(Immediately after endovascular thrombectomy)