DAISe 1 Feasibility Study to Evaluate the DAISe Thrombectomy System for Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-Center, Single Arm, Feasibility Study to Evaluate the DAISe Thrombectomy System During Neurointervention for Acute Ischemic Stroke; DAISe 1 Study

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: DAISe Thrombectomy System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAISe Thrombectomy System<br>Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration. | Device: DAISe Thrombectomy System<br>* DAISe Thrombectomy System for mechanical thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of first pass revascularization success | 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. | procedure | 
| Rate of symptomatic intracranial hemorrhage | 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 | 12-36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful revascularization with the DAISe Device | Successful revascularization of mTICI 2c-3 as a result of the first attempt with the DAISe Thrombectomy Device | Procedure | 
| Rate of procedural final successful revascularization | Successful revascularization of final mTICI 2b-3 at the end of the procedure | Procedure | 
| Rate of successful revascularization at procedure end | Successful revascularization of final mTICI 2c-3 at the end of the procedure | Procedure | 
| Rate of successful device use | Measured by the successful delivery and placement of the DAISe Device in the target artery | Procedure | 
| Procedure time | Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow | Procedure | 
| Complications | Rate of procedure and/or device related complications | Procedure | 
| Rate of ENT | Rate of embolization to a new vascular territory (ENT) during procedure | Procedure | 
| Infarct volume | Infarct volume in MRI (FLAIR/Diffusion Weighted Imaging [DWI] combined) | 12-36 hours | 
| Emboli | Number of emboli outside of main infarct affected territory and outside the affected territory in high-resolution DWI | 12-36 hours | 
| Intracranial hemorrhage | Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification | 12-36 hours | 
| Good functional outcome | Good functional outcome measured by Modified Rankin Score (measured 0 completely functional to 6 deceased) of 0-2 | 3 months | 
| Mortality Rate | All cause mortality | 3 months |