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A prospective, open label, 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 registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 400 subjects at up 20 sites will participate in the study.
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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 |
|---|---|---|
| Recanalization rate of occluded target vessel | Recanalization rate of 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: Only subjects already treated with the NeVa devices can be considered for enrollment.
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
Age ≥18
NIHSS score ≥ 6
Pre-stroke 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 24 hours from symptom onset (defined as time last known well [TLKW])
Imaging Inclusion Criteria:
7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 if treatment started 0-6 hours from TLKW ASPECTS 8-10 if treatment started 6-24 hours from TLKW
7.2. CT Perfusion core ≤50 cc
7.3. MRI DWI core ≤50 cc
Subject or legal representative is able and willing to give informed consent within 48 hours after the intervention.
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 |
|---|---|---|---|---|---|---|
| Vall d'Hebron | Recruiting | 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 |