• The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion Strokes

  NCT03926988

  Unknown statusInterventionalNot ApplicableUpdated Jan 13, 2023
• The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes

  NCT03927001

  Unknown statusInterventionalNot ApplicableUpdated Jan 17, 2023
• The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study

  NCT04514562

  Unknown statusInterventionalNot ApplicableUpdated Jan 17, 2023
• FIrst-Pass Reperfusion With the NeVa Stent-Retriever Trial

  NCT04072367

  WithdrawnInterventionalNot ApplicableUpdated Apr 27, 2023
• NeVa Retrospective Comparative SR Study

  NCT06964724

  Active, not recruitingObservationalUpdated Mar 31, 2026
• Trevo® Retriever Registry Post Market Surveillance

  NCT02040259

  CompletedObservationalUpdated Jun 24, 2020

ClinicalTrials.gov ID

NCT04562194

Lead Sponsor

VesalioINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

600Estimated

Last Update Posted

Mar 31, 2026Actual

Start Date

Jul 1, 2020Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jun 1, 2027Estimated

Official Title

NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry

Brief 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.

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 600 subjects will be enrolled at up 30 sites.

• Acute Ischemic Stroke

• NeVa Stent Retriever

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 middle cerebral 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 (defined as time last known well [TLKW])

6. Imaging Inclusion Criteria:

   The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should 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

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

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

VesalioINDUSTRY

+39 3516775140