Taking people in ItalyNo phase
Tests the NeVa stent retriever to remove clots in people with stroke
Tests the NeVa stent retriever device to remove clots in adults with acute stroke.
Key facts
- Who runs it
- Vesalio
- Where
- Milan, ItalySee the siteAlso in 2 other countries, 2 sites
- Trial code
- Registry title
- NeVa ONE Registry Study
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 1 Jul 2020
- Expected to end
- 1 Jun 2027
- Type of study
- Interventional
- Treatments tested
- NeVa Stent Retriever
- Record updated
- 31 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a stroke caused by a blocked brain artery who were already treated with a NeVa clot-removal device.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with a large blocked artery in the brain shown on DSA, with brain tissue that can still be saved. NIHSS score of 6 or more. Before the stroke, mRS score of 1 or less. Treatment can start within 24 hours from last known well. ASPECTS 6-10 if treatment starts 0-6 hours, ASPECTS 8-10 if 6-24 hours. Ischemic core 50 cc or less.
- Earlier treatment
- Only people already treated with the NeVa thrombectomy devices can join.
Main reasons for not taking part
- Brain, nerve or mental illness that would disturb the evaluations, such as dementia treated with an anti-cholinesterase drug
- Stroke on both sides or in several brain areas
- Brain tumor (except a small meningioma) or a large swelling that shifts the midline of the brain
- Severe allergy to contrast medium or known allergy to NeVa materials (nitinol, stainless steel)
- Life expectancy under 6 months
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- History of severe allergy to contrast medium
- Known allergy to NeVa materials (nitinol, stainless steel)
- Systemic infection
- 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
- Cerebral vasculitis
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
- 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
Where in Italy
Also in 2 other countries, 2 sites
- Niguarda HospitalMilan, ItalyContact: Edoardo BoccardiTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- InterventionOther group
NeVa Stent Retriever
Treatment: NeVa Stent Retriever
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry
- Plain-language title
- Tests the NeVa stent retriever to remove clots in people with strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 31 March 2026