Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Modified Rankin scale
研究概览
简要总结
Aim of Study:
- To develop a standardized patient selection criteria and imaging protocol for endovascular therapy in acute ischaemic stroke (AIS)
- To create a local efficacy and safety database for intra-arterial mechanical thrombectomy devices use
- To establish predictors for poor functional outcome despite successful recanalization
Study Design:
Prospective
Subject and Site:
100 acute ischaemic stroke patients with large vessel occlusion At Queen Mary and Ruttonjee Hospital, Hong Kong
Duration of participation:
2 years
Entry Criteria:
Subject must meet all inclusion criteria and none of the exclusion criteria
Consent:
Both English and Chinese versions of Informed consent are available and will be obtained from patient or his/her next of kin
详细描述
Our study aim to set a standard patient selection and imaging protocol based on previous positive trials for endovascular therapy in AIS patients. Local efficacy and safety data of the FDA mechanical devices mainly Penumbra Aspiration System and Solitaire Flow Restoration device will be collected to create a local database for future service development. Clinical predictors for poor clinical outcomes despite successful recanalization will be looked for.
Intra-arterial treatment consisted of arterial catheterization with a micro-catheter and micro-guide wire to the level of occlusion. Mechanical treatment could involve thrombus aspiration technique or use of a retrievable stent. The method of intra-arterial treatment will leave to the discretion of the involved interventionist. Only devices that have received U.S. Food and Drug Administration (FDA) or Conformite Europeenne (CE) approval will be used in the trial. One or more members of each intervention team have to have completed at least five full procedures with a particular type of device.
Outcome and Safety Measures:
The primary outcome is 90 days modified Rankin scale. The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). A score of 2 or less indicates functional independence.
Secondary outcomes include:
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
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset: ≤ 4.5 hours from symptoms onset
- •Age < 80
- •Premorbid modified Rankin Score (mRS) ≤ 2
- •NIHSS 8 - 29
- •Clear and definite symptoms and signs suggesting stroke with hemiparesis as one of the presenting symptoms
- •Plain CT brain showed no evidence of intracerebral haemorrhage and ASPECTS ≥ 7
- •Multiphasic CT angiogram confirmed proximal vessel occlusion at internal carotid artery (ICA), carotid T junction, proximal middle cerebral artery (M1 segment to proximal M2 with loss of all M2 branches), proximal anterior cerebral artery (segment A1) or basilar artery
排除标准
- •Interventionist or angio-laboratory not available
- •Neurological signs rapidly resolving
- •NIHSS>29
- •Evidence of cerebral haemorrhage or subarachnoid haemorrhage on CT brain
- •ASPECTS<7
- •Excessive tortuosity of the vessel precluding device delivery
- •Known chronic renal failure with creatinine level >250umol/L
- •Known haemorrhagic diathesis
- •Known coagulation factor deficiency
- •Difficult blood pressure control with persistent systolic blood pressure >185mg or diastolic blood pressure >110mg despite aggressive blood pressure lowering therapy
- •On anticoagulant and INR≥3
- •On heparin in previous 48 hour and APTT>2x of normal
- •Platelet counts <30
- •Blood glucose <2.7mmol/L
- •Known severe allergies to contrast medium
- •Seizure as presenting symptoms with post-ictal hemiparesis
- •Life expectancy < 3months
研究组 & 干预措施
Aspiration First
Aspiration thrombectomy with large bore catheters
干预措施: Aspiration First (Device)
Stent retriever first
Thrombectomy with a licensed stent retriever device
干预措施: Stent retriever first (Device)
结局指标
主要结局
Modified Rankin scale
时间窗: 90 days
The primary outcome is 90 days modified Rankin scale. The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). A score of 2 or less indicates functional independence.
次要结局
- Activities of daily living(90 days)
- National Institute of Health Stroke Severity Score (NIHSS)(At 24 hours and at 7 day or discharge if earlier)
- Percentage of successful recanalization(1 day)
研究者
Dr Anderson Chun-On Tsang
Clinical Assistant Professor
The University of Hong Kong