The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    120
  • sponsor
    Vesalio
Updated on 24 July 2021

Summary

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.

Description

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 120 eligible subjects at up 20 sites will participate in the study.

Details
Condition Acute Ischemic Stroke
Treatment NeVa Stent Retrievers
Clinical Study IdentifierNCT04514562
SponsorVesalio
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

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. Subject has failed IV t-PA therapy
2. Subject is contraindicated for IV t-PA administration
3. IV-tPA given within 3 hours of symptom onset
\. Age 18 and 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
1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS
-10 , or
2. CT Perfusion core 50 cc, or
3. MRI DWI core 50 cc
\. Subject or legal representative is able and willing to give informed
consent prior to the intervention

Exclusion Criteria

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)
Cardiopulmonary resuscitation, cardiac arrhythmia resulting in hemodynamic instability (hypotension) that is not easily medically correctable, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration
Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
Cerebral vasculitis
History of severe allergy to contrast medium
Known allergy to NeVa materials (nitinol, stainless steel)
Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
Systemic infection
Significant mass effect with midline shift
Evidence of intracranial tumor (except small meningioma [ 3 cm])
Any CT or MRI evidence of acute hemorrhage products on presentation
Inability to deploy NeVa device for at least one pass for any other reason
Life expectancy less than 6 months
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
Females you are pregnant or breastfeeding
Active malignancy
Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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