The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes

Study Overview
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Brief Summary
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A prospective, open label, single-arm 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Detailed Description
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This is a prospective, open label, multi-center, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 150 subjects at up 20 sites will participate in the study.

Official Title
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Prospective, Open-Label, Multi-Center Single-Arm Trial Designed to Assess the Safety, Performance and Efficacy of the NeVa Stent Retriever in the Treatment of Large Vessel Occlusion Strokes

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: NeVa Stent Retrievers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups: 1.1. Subject has failed IV t-PA therapy 1.2. Subject is contraindicated for IV t-PA administration 1.3. IV-tPA given within 3 hours of symptom onset Age ≥18 and less than equal to 85 NIHSS score ≥ 8 and ≤ 25 Prestroke mRS score of ≤ 1 Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA. Thrombectomy procedure can be initiated within 8 hours from symptom onset (defined as time last known well [TLKW]) and at least one NeVa pass occurring within 8 hours Imaging Inclusion Criteria: 7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or 7.2. CT Perfusion core ≤50 cc, or 7.3. MRI DWI core ≤50 cc Subject or (legal) representative or independent physician (if approved by site's regional ethics committee, see site's informed consent form) is able and willing to give informed consent prior to the interventions. Exclusion Criteria: Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept). Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. Cerebral vasculitis History of severe allergy to contrast medium. Known allergy to NeVa materials (nitinol, stainless steel); Suspicion of aortic dissection, septic embolus, or bacterial endocarditis Systemic infection Significant mass effect with midline shift Evidence of intracranial tumor (except small meningioma [≤ 3cm]) Any CT or MRI evidence of acute hemorrhage products on presentation Inability to deploy NeVA device for at least one pass for any other reason Life expectancy less than 6 months Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. Active malignancy Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Other: Intervention<br>NeVa Stent Retrievers | Device: NeVa Stent Retrievers<br>* mechanical neurothrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recanalization rate of the occluded target vessel | Recanalization rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s). | post-procedure day 0 |