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

Study Overview
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Brief Summary
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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

Official Title
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A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study

Conditions
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Acute Stroke, Cerebral Ischemia

Intervention / Treatment
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* Device: Q Revascularization System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q Revascularization System<br> | Device: Q Revascularization System<br>* Q Revascularization System for mechanical thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful revascularization rate | Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure | Procedure end | 
| Symptomatic intracranial haemorrhage rate | Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4 | 36 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful revascularization rate with study device | Successful revascularization defined as mTICI 2b-3 flow after all aspiration attempts with the study device | Procedure | 
| Successful revascularization rate on the first attempt with study device | Successful revascularization defined as mTICI 2b-3 flow after the first aspiration attempt with the study device | Procedure | 
| Procedure Time | Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow | Procedure | 
| ENT rate | Embolization to a new vascular territory (ENT) during procedure | Procedure | 
| Procedure Complications | Rate of procedure related complications | Procedure through 90 days | 
| ICH | Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification. | 36 hours post procedure | 
| Good functional outcome | Good functional outcome measured by Modified Rankin Score (mRS) defined as a value of 0-2 | 90 days post procedure | 
| Mortality | All cause mortality | 90 days post procedure |