EUCTR2018-004464-57-DE进行中（未招募）1 期
Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke - SWIFT DIRECT
niverstiy Hospital Bern0 个研究点目标入组 404 人开始时间: 2019年3月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 404
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Informed consent as documented by signature
- •-Age = 18 years
- •-Clinical signs consistent with an acute ischaemic stroke
- •-Neurological deficit with a NIHSS of = 5 and < 30 (deficits judged to be clearly disabling at presentation)
- •-Patient is eligible for IV t-PA
- •-Patient is eligible for endovascular treatment/therapy
- •-Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset (onset time is measured from the time when the subject was last seen well)
- •-Occlusion (mTICI 0-1) of the intracranial internal carotid artery, the M1 segment of the middle cerebral artery, or both confirmed by CT or MR angiography, accessible for MT
- •-Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or equal to 4 (= 4) based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •Acute intracranial haemorrhage
- •Any contraindication for IV t-PA
- •Pre-treatment with IV t-PA
- •In-hospital stroke
- •Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
- •Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys
- •Known current participation in a clinical trial
- •Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min and /or known history of renal insufficiency or requirement for haemodialysis or peritoneal dialysis
- •Severe comorbid condition with life expectancy less than 90 days at baseline
- •Known advanced dementia or significant pre-stroke disability (mRS score of = 2)
- •Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
- •Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
- •Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- •Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT
- •Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma)
- •Radiological confirmed evidence of cerebral vasculitis
- •CTA or MRA evidence of carotid dissection
- •Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA
研究者
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