Status:
COMPLETED
A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke
Lead Sponsor:
MIVI Neuroscience, Inc.
Conditions:
Acute Stroke
Cerebral Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04437862
Start Date
October 27 2020
End Date
August 2 2023
Last Update
August 9 2024
Active Locations (8)
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1
University of South Florida
Tampa, Florida, United States, 33620
2
Cooper University Health Care
Camden, New Jersey, United States, 08103
3
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14208
4
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120