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

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

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

Study Overview

• Status: Completed
• Conditions: Acute Stroke; Cerebral Ischemia
• Intervention / Treatment: Device: Q Revascularization System

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU Pellegrin
  • Nancy, France, 54035
    • CHU Urbains
  • Paris, France, 94270
    • CHU Bicetre Paris
  • Toulouse, France, 31059
    • Hopital Purpan
• United States
  • Florida
    • Tampa, Florida, United States, 33620
      • University of South Florida
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Health Care
  • New York
    • Buffalo, New York, United States, 14208
      • University at Buffalo Neurosurgery
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Q Revascularization System	Device: Q Revascularization System; Q Revascularization System for mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful revascularization rate	Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure	Procedure end
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: MIVI Neuroscience, Inc.
• Investigators: Principal Investigator: Christopher Cognard, PhD, MD, Hopital Purpan; Principal Investigator: Lucas Elijovich, MD, University of Tennessee Health Sciences Center; Principal Investigator: Brian Jankowitz, MD, JFK University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Brain Ischemia; Cerebral Infarction
• Other Study ID Numbers: 101773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes