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

MIVI Neuroscience

Status

Completed

Conditions

Cerebral Ischemia

Acute Stroke

Treatments

Device: Q Revascularization System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04437862

101773

Details and patient eligibility

About

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

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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