Clinical Trials

Inclusion Criteria:

• Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
  • Subject has failed IV t-PA therapy;
  • Subject is contraindicated for IV t-PA administration;
  • IV-tPA given within 3 hours of symptom onset.
• Age ≥ 18 and ≤ 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:
  • Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 ; or
  • CT Perfusion core ≤ 50 cc; or
  • MRI DWI core ≤ 50 cc.
• Subject or legal representative is able and willing to give informed consent prior to the intervention

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, cardiac arrhythmia resulting in hemodynamic instability (hypotension) that is not easily medically correctable, 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 [≤ 3 cm]).
• 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.
• Females you are pregnant or breastfeeding.
• Active malignancy.
• Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.