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 sites404 target enrollmentAugust 7, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 7, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niverstiy Hospital Bern

•\-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

•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\)