RecruitingNot Applicable

NeVa ONE Registry Study

Argentina, Italy, United Arab Emirates600 participantsStarted 2020-07-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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

What they're measuring

First Pass Success Rate

Timeframe: post-procedure day 0

Trial details

NCT IDNCT04562194

SponsorVesalio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Antoine Cuijpers

+31 6 51 55 99 37 acuijpers@vesalio.com

View on ClinicalTrials.gov More Acute Ischemic Stroke trials