Actively Recruiting
NeVa ONE Registry Study
Led by Vesalio · Updated on 2026-03-31
600
Participants Needed
3
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NeVa ONE Registry Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Only subjects already treated with the NeVa thrombectomy device can be enrolled
- Age 18 years or older
- NIHSS score of 6 or higher
- Pre-stroke modified Rankin Scale (mRS) score of 1 or less
- Intracranial arterial occlusion in distal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery, posterior cerebral artery, basilar artery, or vertebral artery confirmed by angiography
- Thrombectomy procedure can start within 24 hours from symptom onset (time last known well)
- Imaging confirmation of large vessel occlusion and salvageable brain tissue using any automated software
- ASPECTS score 6-10 if treatment started within 0-6 hours from last known well
- ASPECTS score 8-10 if treatment started within 6-24 hours from last known well
- Ischemic core volume 50 cc or less
- Subject or legal representative able and willing to give informed consent within 72 hours after the intervention
You will not qualify if you...
- Pre-existing neurological or psychiatric disease that would affect evaluations, such as dementia treated with anti-cholinesterase inhibitors
- Cardiopulmonary resuscitation, serious cardiac arrhythmia, ongoing heart attack, or risk of lung aspiration before treatment
- Symptoms suggesting stroke in both brain sides or multiple brain areas
- Cerebral vasculitis
- Severe allergy to contrast medium
- Known allergy to NeVa materials (nitinol, stainless steel)
- Suspected aortic dissection, septic embolus, or bacterial endocarditis
- Systemic infection
- Significant brain swelling causing midline shift
- Presence of intracranial tumor except small meningioma
- Inability to deploy the NeVa device at least once
- Life expectancy less than 6 months
- Any other condition making endovascular procedure unsafe or unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hospital Espanol de Mendoza
Mendoza, Argentina
Actively Recruiting
2
Niguarda Hospital
Milan, Italy
Actively Recruiting
3
Cleveland Clinic Abu Dhabi
Abu Dhabi, United Arab Emirates
Actively Recruiting
Research Team
A
Antoine Cuijpers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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