Overview

A prospective, open label study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Eligibility

Inclusion Criteria:

        Only subjects already treated with the NeVa thrombectomy devices can be considered for
        enrollment.
          1. Age ≥18
          2. NIHSS score ≥ 6
          3. Pre-stroke mRS score ≤ 1
          4. 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.
          5. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as
             time last known well [TLKW])
          6. Imaging Inclusion Criteria:
             The patient should have confirmed LVO and salvageable penumbra. Any automated software
             for determine the volume of viable tissue is acceptable. patient selection should
             follow the following guidelines:
               -  ASPECTS 6-10 if treatment started 0-6 hours from TLKW
               -  ASPECTS 8-10 if treatment started 6-24 hours from TLKW
               -  Ischemic core ≤ 50 cc
          7. Subject or legal representative is able and willing to give informed consent within 72
             hours after the intervention (may use independent physician consent in this timeframe
             and gain subject or legal representative consent later than 72 hours).
        Exclusion Criteria:
          1. 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).
          2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing
             myocardial infarction, concern for pre- treatment pulmonary aspiration.
          3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
          4. Cerebral vasculitis
          5. History of severe allergy to contrast medium.
          6. Known allergy to NeVa materials (nitinol, stainless steel)
          7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
          8. Systemic infection
          9. Significant mass effect with midline shift
         10. Evidence of intracranial tumor (except small meningioma)
         11. Inability to deploy NeVA device for at least one pass for any other reason
         12. Life expectancy less than 6 months
         13. 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.