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

Not Applicable

Completed

Conditions: Cerebral Ischemia
Acute Stroke

Interventions: Device: Q Revascularization System

Registration Number: NCT04437862

Lead Sponsor: MIVI Neuroscience, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 121

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Q Revascularization System	Q Revascularization System	-

Primary Outcome Measures

Name	Time	Method
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
Successful revascularization rate	Procedure end	Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure

Secondary Outcome Measures

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

Trial Locations

Locations (8): CHU Bicetre Paris
🇫🇷
Paris, France
University at Buffalo Neurosurgery
🇺🇸
Buffalo, New York, United States
CHU Urbains
🇫🇷
Nancy, France
CHU Pellegrin
🇫🇷
Bordeaux, France
Cooper University Health Care
🇺🇸
Camden, New Jersey, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
Hôpital Purpan
🇫🇷
Toulouse, France