Acute Ischemic Stroke
Conditions
Keywords
Thrombus, stroke
Brief 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.
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
DEVICENeVa Stent Retriever
mechanical neurothrombectomy
Sponsors
Vesalio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment. 1. Age ≥18 2. NIHSS score ≥ 6 3. Pre-stroke mRS score ≤ 1 4. 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. 5. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[TLKW\]) 6. 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 7. 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
1. 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). 2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration. 3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories 4. Cerebral vasculitis 5. History of severe allergy to contrast medium. 6. Known allergy to NeVa materials (nitinol, stainless steel) 7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis 8. Systemic infection 9. Significant mass effect with midline shift 10. Evidence of intracranial tumor (except small meningioma) 11. Inability to deploy NeVA device for at least one pass for any other reason 12. Life expectancy less than 6 months 13. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Pass Success Rate | post-procedure day 0 | The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B \& eTICI ≥2C |
Countries
Argentina, Italy, United Arab Emirates
Contacts
CONTACTAntoine Cuijpers
Outcome results
None listed