Clinical trial NCT03926988: The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion Strokes
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Vesalio
Sponsor class: INDUSTRY
First posted: 2019-04-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 400 subjects at up 20 sites will participate in the study.

Eligibility criteria: Inclusion Criteria: Only subjects already treated with the NeVa devices can be considered for enrollment.

1. 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
2. Age ≥18
3. NIHSS score ≥ 6
4. Pre-stroke mRS score of ≤ 1
5. 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.
6. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[TLKW\])
7. 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
8. Subject or legal representative is able and willing to give informed consent within 48 hours after the intervention.

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.

Primary outcomes:
measure: Recanalization rate of occluded target vessel
timeFrame: post-procedure day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron
Study officials:
References: