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

Vesalio1 site in 1 country150 target enrollmentApril 1, 2019

ConditionsAcute Ischemic Stroke

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Vesalio
Enrollment: 150
Locations: 1
Primary Endpoint: Recanalization rate of the occluded target vessel
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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 150 subjects at up 20 sites will participate in the study.

Registry

clinicaltrials.gov

Start Date

April 1, 2019

End Date

August 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vesalio

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
•Subject has failed IV t-PA therapy
•Subject is contraindicated for IV t-PA administration
•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:

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, significant cardiac arrhythmia, 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 \[≤ 3cm\])