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

Acute Stroke Clinical Trial

— EvaQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437862
• Other study ID #: 101773
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: August 2, 2023

Study information

• Verified date: April 2024
• Source: MIVI Neuroscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Q Revascularization System
Q Revascularization System for mechanical thrombectomy

Locations

Country	Name	City	State
France	CHU Pellegrin	Bordeaux
France	CHU Urbains	Nancy
France	CHU Bicetre Paris	Paris
France	Hôpital Purpan	Toulouse
United States	University at Buffalo Neurosurgery	Buffalo	New York
United States	Cooper University Health Care	Camden	New Jersey
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MIVI Neuroscience, Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

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