NeVa ONE Registry Study

Last updated: December 19, 2024
Sponsor: Vesalio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Stroke

Blood Clots

Treatment

NeVa Stent Retriever

Clinical Study ID

NCT04562194
VS-003/D
  • Ages > 18
  • All Genders

Study Summary

A prospective, open label study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.

  1. Age ≥18

  2. NIHSS score ≥ 6

  3. Pre-stroke mRS score ≤ 1

  4. Intracranial arterial occlusion of the distal intracranial carotid artery or middlecerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.

  5. Thrombectomy procedure can be initiated within 24 hours from symptom onset (definedas time last known well [TLKW])

  6. Imaging Inclusion Criteria: The patient should have confirmed LVO and salvageable penumbra. Any automatedsoftware for determine the volume of viable tissue is acceptable. patient selectionshould follow the following guidelines:

  • ASPECTS 6-10 if treatment started 0-6 hours from TLKW

  • ASPECTS 8-10 if treatment started 6-24 hours from TLKW

  • Ischemic core ≤ 50 cc

  1. Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in thistimeframe and gain subject or legal representative consent later than 72 hours).

Exclusion

Exclusion Criteria:

  1. Pre-existing medical neurological or psychiatric disease that would confound theneurological or functional evaluations, e.g. dementia with prescribedanti-cholinesterase inhibitor (e.g. Aricept).

  2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoingmyocardial 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 anendovascular procedure or poses a significant hazard to the subject if anendovascular procedure was performed.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: NeVa Stent Retriever
Phase:
Study Start date:
July 01, 2020
Estimated Completion Date:
May 31, 2027

Study 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 600 subjects will be enrolled at up 30 sites.

Connect with a study center

  • Hospital Espanol de Mendoza

    Mendoza,
    Argentina

    Active - Recruiting

  • Niguarda Hospital

    Milan,
    Italy

    Active - Recruiting

  • Cleveland Clinic Abu Dhabi

    Abu Dhabi,
    United Arab Emirates

    Active - Recruiting

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