clinical investigation to compare safety and efficacy of daise and stent retrievers for thrombectomy in acute ischemic stroke patients

Conditions: Stroke; Stroke, Ischemic; Stroke, Acute; Cerebrovascular Disorders; Cerebrovascular Accident

Summary: compare the safety and efficacy of the daise to stent retrievers in the treatment of acute ischemic stroke


Eligibility criteria:
inclusion criteria: * age 18 years and older * pre-stroke independent functional status in activities of daily living with modified rankin score 0-1 * patient presenting with a disabling stroke device as nihss ≥6 * thrombolytic therapy (iv tpa), if indicated/administered, was initiated within 3 hours of onset/ last known well according to prescribed dosing.endovascular treatment intended to be initiated (groin puncture) \<24 hours from onset of symptoms or last known well time. * confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, m1 or proximal m2 segment of the middle cerebral artery. * the following image criteria should also be met: for subjects 0-6hrs onset: * mri criterion: volume of diffusion restriction as assessed by automated core volume software ≤50ml or * ct criterion: aspects 6-10 on baseline ct or cta-source images or, cpt as assessed by automated core volume software ≤50ml for subjects 6-24hrs onset: * ≤20ml ischemic core volume if age \>80 * ≤30ml ischemic core volume if age \<80 and nihss 10-20 * ≤50ml ischemic core volume if age \ 20 * signed informed consent from patient or legal authorized representative. exclusion criteria: * ct or mri evidence of intracranial hemorrhage on presentation. * ct or mri showing mass effect or intracranial tumor (meningioma \>2cm in diameter) * ct or mri evidence of carotid dissection or complete cervical carotid occlusion requiring a stent. * previous stroke within the past 3 months. * known arterial condition (proximal vessel stenosis or pre-existing stent) that would prevent the study devices from reaching the target vessel and/or preclude safe recovery of the study devices. * pregnancy. * severe contrast allergy or absolute contraindication to iodinated contrast. * rapidly improving neurological status as determined by investigator/neurologist. * renal failure/insufficiency with \>3.0 mg/dl creatinine prior to procedure. * severe, sustained hypertension resistant to treatment (sbp\>185mmhg or dbp \>110mmhg) * use of warfarin anticoagulation with international normalized ratio (inr) \>3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency. * for patients who have received a direct thrombin inhibitor within the last 48hrs; partial thromboplastin time (ptt) \> 2.0 times the normal prior to procedure. * platelet count \< 50,000 * cerebral vasculitis or evidence of active systemic infection (including covid-19) * suspicion of aortic dissection, septic embolus, or bacterial endocarditis. * clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation). * seizure due to stroke. * clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. * active participation in another study involving an investigational drug or device. * a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. * unwillingness to complete follow up visits.

Keywords: daise thrombectomy