Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 404

Inclusion Criteria

-Informed consent as documented by signature
-Age = 18
-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 ASPECTS greater than or equal to 4 (= 4) based on baseline CT or 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 104

Exclusion Criteria

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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