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

NCT ID: NCT04437862

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2023-08-02

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

Conditions

Acute Stroke; Cerebral Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Q Revascularization System

Group Type: EXPERIMENTAL

Q Revascularization System

Intervention Type: DEVICE

Q Revascularization System for mechanical thrombectomy

Interventions

Q Revascularization System

Q Revascularization System for mechanical thrombectomy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MIVI Neuroscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Cognard, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Purpan

Lucas Elijovich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Health Sciences Center

Brian Jankowitz, MD

Role: PRINCIPAL_INVESTIGATOR

JFK University Medical Center

Locations

University of South Florida

Tampa, Florida, United States

Cooper University Health Care

Camden, New Jersey, United States

University at Buffalo Neurosurgery

Buffalo, New York, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

CHU Pellegrin

Bordeaux, , France

CHU Urbains

Nancy, , France

CHU Bicetre Paris

Paris, , France

Hôpital Purpan

Toulouse, , France

Countries

United States; France

Other Identifiers

101773

Identifier Type: -

Identifier Source: org_study_id