A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke

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