Clinical trial NCT04437862: A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke
Official title: A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Cerebral Ischemia
Lead sponsor: MIVI Neuroscience, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Successful revascularization rate
timeFrame: Procedure end
measure: Symptomatic intracranial haemorrhage rate
timeFrame: 36 hours post procedure
Secondary outcomes:
measure: Successful revascularization rate with study device
timeFrame: Procedure
measure: Successful revascularization rate on the first attempt with study device
timeFrame: Procedure
measure: Procedure Time
timeFrame: Procedure
measure: ENT rate
timeFrame: Procedure
measure: Procedure Complications
timeFrame: Procedure through 90 days
measure: ICH
timeFrame: 36 hours post procedure
measure: Good functional outcome
timeFrame: 90 days post procedure
measure: Mortality
timeFrame: 90 days post procedure
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo Neurosurgery
state: New York
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Nancy
country: France
facility: CHU Urbains
city: Paris
country: France
facility: CHU Bicetre Paris
city: Toulouse
country: France
facility: Hôpital Purpan
Study officials:
affiliation: Hôpital Purpan
name: Christopher Cognard, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee Health Sciences Center
name: Lucas Elijovich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JFK University Medical Center
name: Brian Jankowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: