Acute Stroke, Cerebral Ischemia
Conditions
Brief 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
Interventions
DEVICEQ Revascularization System
Q Revascularization System for mechanical thrombectomy
Sponsors
MIVI Neuroscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful revascularization rate | Procedure end | Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure |
| Symptomatic intracranial haemorrhage rate | 36 hours post procedure | Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | Procedure | Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow |
| ENT rate | Procedure | Embolization to a new vascular territory (ENT) during procedure |
| Procedure Complications | Procedure through 90 days | Rate of procedure related complications |
| Successful revascularization rate with study device | Procedure | Successful revascularization defined as mTICI 2b-3 flow after all aspiration attempts with the study device |
| Good functional outcome | 90 days post procedure | Good functional outcome measured by Modified Rankin Score (mRS) defined as a value of 0-2 |
| Mortality | 90 days post procedure | All cause mortality |
| ICH | 36 hours post procedure | Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification. |
| Successful revascularization rate on the first attempt with study device | Procedure | Successful revascularization defined as mTICI 2b-3 flow after the first aspiration attempt with the study device |
Countries
France, United States
Outcome results
None listed