Phase
Condition
Thrombosis
Stroke
Blood Clots
Treatment
NeVa Stent Retriever
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
Age ≥18
NIHSS score ≥ 6
Pre-stroke mRS score ≤ 1
Intracranial arterial occlusion of the distal intracranial carotid artery or middlecerebral 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 24 hours from symptom onset (definedas time last known well [TLKW])
Imaging Inclusion Criteria: The patient should have confirmed LVO and salvageable penumbra. Any automatedsoftware for determine the volume of viable tissue is acceptable. patient selectionshould 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
- Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in thistimeframe and gain subject or legal representative consent later than 72 hours).
Exclusion
Exclusion Criteria:
Pre-existing medical neurological or psychiatric disease that would confound theneurological or functional evaluations, e.g. dementia with prescribedanti-cholinesterase inhibitor (e.g. Aricept).
Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoingmyocardial 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)
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 anendovascular procedure or poses a significant hazard to the subject if anendovascular procedure was performed.
Study Design
Study Description
Connect with a study center
Hospital Espanol de Mendoza
Mendoza,
ArgentinaActive - Recruiting
Niguarda Hospital
Milan,
ItalyActive - Recruiting
Cleveland Clinic Abu Dhabi
Abu Dhabi,
United Arab EmiratesActive - Recruiting
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