a study to evaluate the q revascularization system for neurointervention in acute ischemic stroke

Conditions: Acute Stroke; Cerebral Ischemia

Summary: assess the safety and efficacy of the q revascularization system to remove thrombi and emboli from the neurovasculature in patients experiencing an acute ischemic stroke


Eligibility criteria:
inclusion criteria: * age 18 years or older. * pre-stroke independent functional status in activities of daily living with mrs 0-1. * a disabling stroke defined as nihss ≥ 6 * in usa thrombolytic therapy (iv tpa) received within 3 hours of onset/ last known well, in europe treatment with iv tpa received within 4.5 hours from onset/ last known well or ineligibility for thrombolytic therapy * endovascular treatment intended to be initiated \< 8 hours from onset of symptoms or last known well time * confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, m1, m2, basilar or intracerebral vertebral artery by baseline neuroimaging cta/mra and angiographic imaging with a mtici score 0-1 * for strokes in the anterior circulation the following imaging criteria should also be met: mri criterion of volume of diffusion restriction visually assessed ≤50 ml or ct criterion of aspects 6 to 10 on baseline ct or cta-source images or, significantly lowered cerebral blood volume (cbv) ≤50 ml * for strokes in the basilar or vertebral artery, the following imaging criterion should also be met: pc-aspects score 8 to 10 on baseline ct, cta-source images, or mri * signed informed consent from subject, acceptable person responsible (e.g. lar) and/or according to county specific regulatory requirements and local ethical committee or review board requirements exclusion criteria: * ct or mri evidence of intracranial hemorrhage on presentation * ct or mri showing mass effect or intracranial tumor (meningioma \> 2 cm in diameter). * previous stroke within the past 3 months * 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 \>185 mmhg or dbp \>110 mmhg) * 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 48 hours; partial thromboplastin time (ptt) \> 2.0 times the normal prior to procedure * platelet count \< 50,000 mm3 * 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 * pregnancy * severe contrast allergy or absolute contraindication to iodinated contrast * presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure * difficult endovascular access or 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 * 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