Withdrawn, considering alternative trial design

Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke

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 <80 and NIHSS >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.