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NeVa ONE Registry Study

NCT ID: NCT04562194

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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Acute Ischemic Stroke

Keywords

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Thrombus stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

NeVa Stent Retriever

Group Type OTHER

NeVa Stent Retriever

Intervention Type DEVICE

mechanical neurothrombectomy

Interventions

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NeVa Stent Retriever

mechanical neurothrombectomy

Intervention Type DEVICE

Eligibility Criteria

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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 \[TLKW\])

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vesalio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Espanol de Mendoza

Mendoza, , Argentina

Site Status RECRUITING

Niguarda Hospital

Milan, , Italy

Site Status RECRUITING

Cleveland Clinic Abu Dhabi

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Countries

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Argentina Italy United Arab Emirates

Central Contacts

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Antoine Cuijpers

Role: CONTACT

Phone: +31 6 51 55 99 37

Email: [email protected]

Facility Contacts

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Fernando Petra, MD

Role: primary

Edoardo Boccardi

Role: primary

John Shelby, MD

Role: primary

Other Identifiers

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VS-003/D

Identifier Type: -

Identifier Source: org_study_id