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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | NeVa Stent Retriever |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeVa Stent Retriever | Device | mechanical neurothrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| First Pass Success Rate | The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B & eTICI ≥2C | post-procedure day 0 |
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Inclusion Criteria:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine Cuijpers | Contact | +31 6 51 55 99 37 | acuijpers@vesalio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Espanol de Mendoza | Recruiting | Mendoza | Argentina |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D013927 | Thrombosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Niguarda Hospital | Recruiting | Milan | Italy |
|
| Cleveland Clinic Abu Dhabi | Recruiting | Abu Dhabi | United Arab Emirates |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |