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A prospective, open label, single-arm 90-day 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, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 150 subjects at up 20 sites will participate in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | NeVa Stent Retrievers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeVa Stent Retrievers | Device | mechanical neurothrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recanalization rate of the occluded target vessel | Recanalization rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following three or less passes using the NeVa device(s). | post-procedure day 0 |
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Inclusion Criteria:
Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
1.1. Subject has failed IV t-PA therapy
1.2. Subject is contraindicated for IV t-PA administration
1.3. IV-tPA given within 3 hours of symptom onset
Age ≥18 and less than equal to 85
NIHSS score ≥ 8 and ≤ 25
Prestroke mRS score of ≤ 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 8 hours from symptom onset (defined as time last known well [TLKW]) and at least one NeVa pass occurring within 8 hours
Imaging Inclusion Criteria:
7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or
7.2. CT Perfusion core ≤50 cc, or
7.3. MRI DWI core ≤50 cc
Subject or (legal) representative or independent physician (if approved by site's regional ethics committee, see site's informed consent form) is able and willing to give informed consent prior to the interventions.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d'Hebron | Barcelona | Spain |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |