NeVa ONE Registry Study

Official title

NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry

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.

Detailed description

This is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 600 subjects will be enrolled at up 30 sites.

Interventions

• Device NeVa Stent Retriever
  mechanical neurothrombectomy

Primary outcome measures

• First Pass Success Rate [Time frame: post-procedure day 0]

Eligibility criteria

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 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 24 hours from symptom onset (defined as time last known well \[TLKW\])
• 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
• 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

• 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
• 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 an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Argentina · 1 center

• Hospital Espanol de Mendoza — Mendoza

Italy · 1 center

• Niguarda Hospital — Milan

United Arab Emirates · 1 center

• Cleveland Clinic Abu Dhabi — Abu Dhabi

Identifiers

NCT: NCT04562194 · VS-003/D

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗