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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
NeVa Stent Retriever
Devicemechanical neurothrombectomy
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
First Pass Success Rate
The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B \& eTICI ≥2C
Time frame
post-procedure day 0 Source ClinicalTrials.gov