Acute Ischemic StrokeNCT04562194
NeVa ONE Registry Study
A study testing NeVa Stent Retriever in people with Acute Ischemic Stroke, run by Vesalio at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- NeVa Stent Retriever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jul 2020to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
- Age ≥18
- NIHSS score ≥ 6
- Pre-stroke mRS score ≤ 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 24 hours from symptom onset (defined as time last known well [TLKW])
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- 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
- 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).
Who cannot join
- 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)
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- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
- Systemic infection
- Significant mass effect with midline shift
- Evidence of intracranial tumor (except small meningioma)
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Argentina1 site, 1 recruiting
- Recruiting
Hospital Espanol de Mendoza
Mendoza
Fernando Petra, MD
Italy1 site, 1 recruiting
- Recruiting
Niguarda Hospital
Milan
Edoardo Boccardi, +39 3516775140
United Arab Emirates1 site, 1 recruiting
- Recruiting
Cleveland Clinic Abu Dhabi
Abu Dhabi
John Shelby, MD, +971 2 659 0200
About this study
Official title: NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- NeVa Stent Retriever
- Keywords
- Thrombus, stroke
- Medical subject headings
- Ischemic Stroke, Thrombosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeVa Stent RetrieverDevice
mechanical neurothrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | NeVa Stent Retriever Receives: Device: NeVa Stent Retriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Success Rate
The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B \& eTICI ≥2C
Measured: post-procedure day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vesalio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562194
- Sponsor's protocol ID
- VS-003/D
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2020
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry
- ClinicalTrials.gov ID
- NCT04562194
- Acronym / sponsor ID
- VS-003/D
- Conditions
- Acute Ischemic Stroke
- Keywords
- Thrombus, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- VesalioIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: NeVa Stent RetrieverNeVa Stent Retriever |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
- Age ≥18
- NIHSS score ≥ 6
- Pre-stroke mRS score ≤ 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeVa Stent Retrievermechanical neurothrombectomy | Device | Intervention |
Primary outcome
First Pass Success Rate
Time frame: post-procedure day 0
The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B \& eTICI ≥2C
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeVa Stent Retriever in people with Acute Ischemic Stroke, run by Vesalio at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina, Italy, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Cuijpers (+31 6 51 55 99 37, acuijpers@vesalio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Pass Success Rate (time frame: post-procedure day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.