daise 1 feasibility study to evaluate the daise thrombectomy system for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. the maximum enrollment is 10 subjects per site. a maximum of 6 investigational centers in europe will participate. enrollment is expected to take about 9 months, subject participation will last about 3 months.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified rankin score 0-1. patient must be living in their own home, apartment or seniors lodge where no nursing care is required. * diagnosis of acute ischemic stroke and referred to interventional neuroradiology center for mechanical thrombectomy with study enrollment time planned within 8 hours from onset of symptoms. * disabling stroke defined as a baseline nihss \> 6. * thrombolytic therapy (iv tpa) received within 4.5 hours of onset/ last known well according to prescribed dosing or documented ineligibility for thrombolytic therapy. * confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, m1, or m2 with mtici 0-1. * the following baseline imaging criteria should be met: mri criterion- volume of diffusion restriction visually assessed ≤50 ml or aspects score 5-10 or t criterion- aspects 6-10 on imaging ne-ct, cta and/or ctp available * signed informed consent from patient or legal representative or if applicable, documented medical necessity for inclusion in a clinical study in an emergency followed by signed informed consent. * patient is affiliated in the social security system. exclusion criteria: * computed tomography (ct) or magnetic resonance imaging (mri) evidence of recent/ fresh hemorrhage on presentation. * clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. * rapidly improving neurological deficits based on the investigator's clinical judgement. * pregnancy; if a woman is of child-bearing potential and urine or serum beta hcg test is positive. * severe contrast allergy or absolute contraindication to iodinated contrast. * renal failure (serum creatinine level ≥ 3 mg/dl or on dialysis). * severe, sustained hypertension resistant to treatment (sbp \>185 mmhg or dbp \>110 mmhg). * use of warfarin anticoagulation (or other applicable anti-vitamin k anticoagulants) with international normalized ratio (inr) \> 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency. * use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (ptt) \> 2.0 times the normal prior to procedure. * cerebral vasculitis or evidence of active systemic infection. * suspicion of aortic dissection, presumed septic embolus or suspicion of 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. * difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy. * evidence of dissection in the carotid or target artery for treatment. * presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure. * a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. * patient cannot undergo an mri of the head due to mri contraindication. * patient is unable or unwilling complete follow up visits. * if before the stroke, the patient is under a legal protective measure, they will not be able to participate in the study.