Stroke AcuteNITRONCT06964724
NeVa Retrospective Comparative SR Study
An observational study of Stroke Acute, run by Vesalio at 5 sites in 5 countries.
Trial summary
To compare safety and effectiveness of NeVa Stent Retriever (SR) to Control SR in the treatment of stroke caused by large vessel occlusion. The main questions it aims to answer are: How do recanalization rates for NeVa SR compare with those of the Control SR? How does NeVa SR safety compare with Control SR safety? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- What is being tested?
- Mechanical thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 15 Jun 2025to 1 Sep 2026
- Phase
- Observational
- 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
Study population: Subjects suffering from acute ischemic stroke from large vessel occlusion treated with study device.
Who may be able to join
- Treatment during the enrollment period
- Age ≥18
- Baseline modified Thrombolysis in Cerebral Infarction (mTICI) score ≤ 1
- Pre-stroke modified Rankin score (mRS) of 0 or 1
- Internal Carotid Artery (ICA), Middle Cerebral Artery (first segment M1/ second segment M2), basilar artery or vertebral artery occlusion
- National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 and ≤ 25
- Thrombectomy procedure initiated within 8h of Time Last Known Well (TLKW)
- Intravenous Tissue Plasminogen Activator (IV-tPA) failed, given within 3h of TLKW, or ineligibility for thrombolytic drug
Who cannot join
- First line contact aspiration alone or non-study device as first-line device
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: NeVa International, MulTi-center, Retrospective cOmparative Stent Retriever Study
To compare safety and effectiveness of NeVa Stent Retriever (SR) to Control SR in the treatment of stroke caused by large vessel occlusion. The main questions it aims to answer are:
How do recanalization rates for NeVa SR compare with those of the Control SR? How does NeVa SR safety compare with Control SR safety?
Read the detailed description
NITRO is a multicenter, retrospective, comparative, non-inferiority, cohort study designed to compare NeVa SR with Control SR for safety and effectiveness when removing thrombus in subjects presenting with acute ischemic stroke (AIS) due to large vessel occlusion (LVO). The objective of the NeVa International, Multi-center, Retrospective Comparative stent retriever (SR) study (NITRO) study is to compare safety and effectiveness of the NeVa SR to commonly used SR with CE-mark, and US FDA clearance, to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. NITRO aims to collect data describing real-world clinical practices when using SRs according to their indicated use within the indicated population. As such, the eligibility criteria define patients who are diagnosed with AIS and are indicated for endovascular MT aligning to the target population for the proposed device. The present study will include data from subjects treated with either NeVa SR or one of the Control SR. Control SR will include any SR commonly used in thrombectomy trials as first-line strategies and which represent CE-mark, and US FDA cleared stent retrievers.
- Conditions
- Stroke Acute
- Being tested
- Mechanical thrombectomy
- Keywords
- NeVa, Mechanical Thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyProcedure or surgery
Mechanical thrombectomy with stent retriever
| Study group | Role | What they receive |
|---|---|---|
| Patients experiencing acute ischemic stroke due to large vessel occlusion | According to Guidelines AIS patients due to LVO should receive mechanical thrombectomy (with a stent retriever) under certain conditions. Receives: Procedure: Mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reperfusion Effectiveness
Number of patients with a Modified Thrombolysis in cerebral infarction (mTICI) ≥2B and mTICI≥2C recanalization after 1st pass and at end of procedure
Measured: Procedural
Secondary outcomes (3)
Procedural symptomatic bleeding events
Number of patients experiencing symptomatic intracranial hemorrhage (sICH)
Measured: Within 24 hours post intervention
Procedure Safety
Number of patients experiencing procedure related serious Adverse Events (PRSAE)
Measured: Within 24 hours post intervention
Device relationship to serious adverse events
Number of patients experiencing a serious adverse device effect (SADE)
Measured: Within 24 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start15 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vesalio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antoine Cuijpers, MSc, Study director, Vesalio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964724
- Sponsor's protocol ID
- VS-010
- Acronym
- NITRO
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage not yet discussed how or at which URL the Protocol defined Endpoints will be made available.
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 International, MulTi-center, Retrospective cOmparative Stent Retriever Study
- ClinicalTrials.gov ID
- NCT06964724
- Acronym / sponsor ID
- NITRO / VS-010
- Conditions
- Stroke Acute
- Keywords
- NeVa, Mechanical Thrombectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- VesalioIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 May 2025 (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.
To compare safety and effectiveness of NeVa Stent Retriever (SR) to Control SR in the treatment of stroke caused by large vessel occlusion. The main questions it aims to answer are:
How do recanalization rates for NeVa SR compare with those of the Control SR? How does NeVa SR safety compare with Control SR safety?
Detailed description
NITRO is a multicenter, retrospective, comparative, non-inferiority, cohort study designed to compare NeVa SR with Control SR for safety and effectiveness when removing thrombus in subjects presenting with acute ischemic stroke (AIS) due to large vessel occlusion (LVO). The objective of the NeVa International, Multi-center, Retrospective Comparative stent retriever (SR) study (NITRO) study is to compare safety and effectiveness of the NeVa SR to commonly used SR with CE-mark, and US FDA clearance, to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. NITRO aims to collect data describing real-world clinical practices when using SRs according to their indicated use within the indicated population. As such, the eligibility criteria define patients who are diagnosed with AIS and are indicated for endovascular MT aligning to the target population for the proposed device. The present study will include data from subjects treated with either NeVa SR or one of the Control SR. Control SR will include any SR commonly used in thrombectomy trials as first-line strategies and which represent CE-mark, and US FDA cleared stent retrievers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients experiencing acute ischemic stroke due to large vessel occlusion | – | Procedure: Mechanical thrombectomyAccording to Guidelines AIS patients due to LVO should receive mechanical thrombectomy (with a stent retriever) under certain conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from acute ischemic stroke from large vessel occlusion treated with study device.
Key inclusion criteria (8 listed)
- Treatment during the enrollment period
- Age ≥18
- Baseline modified Thrombolysis in Cerebral Infarction (mTICI) score ≤ 1
- Pre-stroke modified Rankin score (mRS) of 0 or 1
- Internal Carotid Artery (ICA), Middle Cerebral Artery (first segment M1/ second segment M2), basilar artery or vertebral artery occlusion
Key exclusion criteria (1 listed)
- First line contact aspiration alone or non-study device as first-line device
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 |
|---|---|---|
| Mechanical thrombectomyMechanical thrombectomy with stent retriever | Procedure or surgery | Patients experiencing acute ischemic stroke due to large vessel occlusion |
Primary outcome
Reperfusion Effectiveness
Time frame: Procedural
Number of patients with a Modified Thrombolysis in cerebral infarction (mTICI) ≥2B and mTICI≥2C recanalization after 1st pass and at end of procedure
3 secondary outcomes
Procedural symptomatic bleeding events
Time frame: Within 24 hours post intervention
Procedure Safety
Time frame: Within 24 hours post intervention
Device relationship to serious adverse events
Time frame: Within 24 hours post intervention
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.
- Individual participant dataSharing planned: Undecided. At this stage not yet discussed how or at which URL the Protocol defined Endpoints will be made available.
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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. This study is not recruiting at the moment.
Antoine Cuijpers, MSc study director
Vesalio
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Acute, run by Vesalio at 5 sites in 5 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 8 inclusion and 1 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: under way, not looking for participants, 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 5 sites in Argentina, Belgium, Germany, Lithuania, Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reperfusion Effectiveness (time frame: Procedural). 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.