NeVa ONE Registry Study
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVesalio
About this trial
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 criteria
Qualifiers
Age ≥18
NIHSS score ≥ 6
Pre-stroke mRS score ≤ 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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- NeVa Stent Retriever
Treatment groups
600 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov