NeVa ONE Registry Study
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.
| Condition(s) | Acute Ischemic Stroke |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 start |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Vesalio |
| Locations | Mendoza, Argentina; Milan, Italy; Abu Dhabi, United Arab Emirates |
| Start date | 2020-07-01 |
| NCT ID | NCT04562194 |
| Official listing | https://clinicaltrials.gov/study/NCT04562194 |