Acute Ischemic Stroke
Conditions
Brief summary
The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 3 months.
Interventions
DEVICEDAISe Thrombectomy System
DAISe Thrombectomy System for mechanical thrombectomy
Sponsors
MIVI Neuroscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required. * Diagnosis of acute ischemic stroke and referred to interventional neuroradiology center for mechanical thrombectomy with study enrollment time planned within 8 hours from onset of symptoms. * Disabling stroke defined as a baseline NIHSS \> 6. * Thrombolytic therapy (IV tPA) received within 4.5 hours of onset/ last known well according to prescribed dosing OR documented ineligibility for thrombolytic therapy. * Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, or M2 with mTICI 0-1. * The following baseline imaging criteria should be met: MRI criterion- volume of diffusion restriction visually assessed ≤50 mL OR ASPECTs score 5-10 or T criterion- ASPECTS 6-10 on imaging NE-CT, CTA and/or CTP available * Signed informed consent from patient or legal representative or if applicable, documented medical necessity for inclusion in a clinical study in an emergency followed by signed informed consent. * Patient is affiliated in the social security system.
Exclusion criteria
* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation. * Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. * Rapidly improving neurological deficits based on the investigator's clinical judgement. * Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive. * Severe contrast allergy or absolute contraindication to iodinated contrast. * Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis). * Severe, sustained hypertension resistant to treatment (SBP \>185 mmHg or DBP \>110 mmHg). * Use of warfarin anticoagulation (or other applicable anti-vitamin k anticoagulants) with International Normalized Ratio (INR) \> 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency. * Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) \> 2.0 times the normal prior to procedure. * 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. * Difficult endovascular access, 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. * Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure. * A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. * Patient cannot undergo an MRI of the head due to MRI contraindication. * Patient is unable or unwilling complete follow up visits. * If before the stroke, the patient is under a legal protective measure, they will not be able to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of first pass revascularization success | procedure | First pass successful revascularization defined as mTICI (modified Treatment in Cerebral Ischemia) 2b-3 flow in the target vessel post-treatment with the DAISe Thrombectomy System used with aspiration. |
| Rate of symptomatic intracranial hemorrhage | 12-36 hours | Symptomatic intracranial haemorrhage at 24 (+/-12) hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful revascularization at procedure end | Procedure | Successful revascularization of final mTICI 2c-3 at the end of the procedure |
| Rate of successful device use | Procedure | Measured by the successful delivery and placement of the DAISe Device in the target artery |
| Procedure time | Procedure | Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow |
| Complications | Procedure | Rate of procedure and/or device related complications |
| Rate of ENT | Procedure | Rate of embolization to a new vascular territory (ENT) during procedure |
| Rate of successful revascularization with the DAISe Device | Procedure | Successful revascularization of mTICI 2c-3 as a result of the first attempt with the DAISe Thrombectomy Device |
| Emboli | 12-36 hours | Number of emboli outside of main infarct affected territory and outside the affected territory in high-resolution DWI |
| Intracranial hemorrhage | 12-36 hours | Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification |
| Good functional outcome | 3 months | Good functional outcome measured by Modified Rankin Score (measured 0 completely functional to 6 deceased) of 0-2 |
| Mortality Rate | 3 months | All cause mortality |
| Infarct volume | 12-36 hours | Infarct volume in MRI (FLAIR/Diffusion Weighted Imaging \[DWI\] combined) |
| Rate of procedural final successful revascularization | Procedure | Successful revascularization of final mTICI 2b-3 at the end of the procedure |
Countries
France
Outcome results
None listed