Acute Ischemic Stroke4-NiVONCT07357285
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
A study testing Thromboaspiration catheter in people with Acute Ischemic Stroke, run by iVascular S.L.U. at 11 sites in 3 countries.
Trial summary
Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions. 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?
- Thromboaspiration catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 27 Nov 2025to Nov 2026
- 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
- Subjects aged ≥ 18 years.
- Subjects with symptom onset up to 24 hours.
- Isolated primary demonstrated occlusion in a distal medium vessel (Non-dominant or distal M2-MCA segment, M3 or M4 segments of MCA, A2-A3 segments of ACA, P1, P2 and P3 segments of PCA) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
- Baseline NIHSS score ≥5 assessed before the procedure.
- Pre-stroke mRS score ≤ 2.
- Subjects with an ASPECTS score ≥ 6.
- Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).
Who cannot join
- Subjects aged < 18.
- Suspected secondary DMVO. Suspicion or evidence of primary LVO whether it has been treated or not with fibrinolytic therapy or mechanical thrombectomy that subsequently develops a DMVO.
- Baseline NIHSS score <5 assessed before the procedure.
- Pre-stroke mRS score >2.
- Subjects with an ASPECTS score <6.
- Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.
Show all 14Show fewer
- Severe allergy to contrast media.
- Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
- Medical history of thrombocytopenia (Platelets <100,000).
- Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery).
- Subjects with occlusions in multiple vessels (e.g., MCA-M3 and ACA-A2), whether or not they undergo mechanical thrombectomy.
- Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months.
- Subjects participating in a clinical trial at the moment of the inclusion.
- Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Germany5 sites
Universitätsklinikum Bonn
Bonn
Universitätsklinikum Schleswig-Holstein
Kiel
Klinikum Marburg
Marburg
Klinikum Nürnberg
Nuremberg
Knappschaftskrankenhaus Recklinghausen
Recklinghausen
Spain5 sites
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario de Getafe
Madrid
Hospital Universitario La Paz
Madrid
Hospital Clínico Universitario Virgen de Arrixaca
Murcia
About this study
Official title: Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO).
Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.
Read the detailed description
This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation.
In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Thromboaspiration catheter
- Keywords
- Stroke, Ischemia, Thromboaspiration
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thromboaspiration catheterDevice
Patients to undergo thromboaspiration with iNstroke 4F
| Study group | Role | What they receive |
|---|---|---|
| Thromboaspiration using iNstroke 4F aspiration catheter | Other | No comparator will be used in this clinical investigation as it is an exploratory study of a CE-marked medical device to be used within the scope of its intended purpose. Receives: Device: Thromboaspiration catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization Endpoint
Recanalization rate with a modified thrombolysis in cerebral infarction scale (mTICI) score ≥2b in ≤3 revascularization passes using iNstroke 4F aspiration catheter, alone or in conjunction with a SR.
Measured: Intra-procedure
Secondary outcomes (12)
Recanalization Endpoint
Proportion of subjects treated with iNstroke 4F alone with complete recanalization in primary DMVO defined as an mTICI ≥2b, after iNstroke 4F aspiration catheter alone (ADAPT) was used as a first-line therapy
Measured: Intra-procedure
Recanalization Endpoint
Proportion of subjects treated with iNstroke 4F in conjunction with a stent retriever having complete recanalization in primary DMVO defined as achieving an mTICI ≥2b, after iNstroke 4F aspiration catheter, in conjunction with a stent retriever (SR), was used as a first-line therapy.
Measured: Intra-procedure
Recanalization Endpoint
Proportion of subjects with mTICI≥2b, mTICI≥2c and mTICI 3 after first pass with iNstroke 4F aspiration catheter used both alone and in conjunction with a SR.
Measured: Intra-procedure
Recanalization Endpoint
Time from groin puncture to achievement of complete recanalization (mTICI ≥2b), or if not achieved, until the final angiogram time, in patients treated with iNstroke 4F aspiration catheter, alone or in conjunction with a SR, as a first-line therapy.
Measured: Intra-procedure
Recanalization Endpoint
Proportion of subjects in which direct contact with thrombus is achieved with iNstroke 4F aspiration catheter.
Measured: Intra-procedure
Clinical Endpoint
Proportion of subjects achieving a modified Rankin scale (mRS) score of 0-2 at the 90-day (±14 days) post-procedure follow-up visit.
Measured: 90 day
Safety Endpoint
Occurrence of SICH (according to SITS-MOST (13) and ECASS criteria (14)) within 24 (-8/+12) hours post-procedure, assessed by magnetic resonance imaging (MRI)/computed tomography (CT).
Intracerebral Haemorrhage (ICH) is defined as the presence of extravascular blood in the brain or within the skull (local or remote parenchymal hematoma type 2, subarachnoid haemorrhage, and/or intraventricular haemorrhage) detected on the post-procedure imaging scan. ICH is considered symptomatic (SICH) if it is associated with a clinical deterioration, determined by a worsening/increase on the National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points, or if it causes death and is identified as the predominant cause of neurological deterioration.
Measured: 24 (-8/+12) hours
Safety Endpoint
Occurrence of embolization in a previously non-involved (or new) territory as seen on the final control angiogram at the end of the procedure.
Measured: Intra-procedure
Safety Endpoint
Occurrence of embolization in distal medium territory to the proximal occlusion as seen on the final control angiogram at the end of the procedure.
Measured: Intra-procedure
Safety Endpoint
Inhospital mortality rate related to the procedure during hospital admission.
Measured: During hospital admission
Safety Endpoint
Occurrence of devices and procedure related adverse events within 90 days (±14 days) after the procedure.
Measured: 90 days (±14 days) after the procedure.
Safety Endpoint
Occurrence of procedure-related complications: arterial perforation, arterial dissection and severe vasospasm in the target vessel.
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start27 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (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
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357285
- Sponsor's protocol ID
- 4-NiVO-01
- Acronym
- 4-NiVO
- Status last verified
- Nov 2026
- First submitted
- 9 Dec 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO).
- ClinicalTrials.gov ID
- NCT07357285
- Acronym / sponsor ID
- 4-NiVO / 4-NiVO-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Ischemia, Thromboaspiration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.
Detailed description
This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation.
In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thromboaspiration using iNstroke 4F aspiration catheter | Other | Device: Thromboaspiration catheterNo comparator will be used in this clinical investigation as it is an exploratory study of a CE-marked medical device to be used within the scope of its intended purpose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged ≥ 18 years.
- Subjects with symptom onset up to 24 hours.
- Isolated primary demonstrated occlusion in a distal medium vessel (Non-dominant or distal M2-MCA segment, M3 or M4 segments of MCA, A2-A3 segments of ACA, P1, P2 and P3 segments of PCA) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
- Baseline NIHSS score ≥5 assessed before the procedure.
- Pre-stroke mRS score ≤ 2.
Key exclusion criteria (14 listed)
- Subjects aged < 18.
- Suspected secondary DMVO. Suspicion or evidence of primary LVO whether it has been treated or not with fibrinolytic therapy or mechanical thrombectomy that subsequently develops a DMVO.
- Baseline NIHSS score <5 assessed before the procedure.
- Pre-stroke mRS score >2.
- Subjects with an ASPECTS score <6.
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 |
|---|---|---|
| Thromboaspiration catheterPatients to undergo thromboaspiration with iNstroke 4F | Device | Thromboaspiration using iNstroke 4F aspiration catheter |
Primary outcome
Recanalization Endpoint
Time frame: Intra-procedure
Recanalization rate with a modified thrombolysis in cerebral infarction scale (mTICI) score ≥2b in ≤3 revascularization passes using iNstroke 4F aspiration catheter, alone or in conjunction with a SR.
12 secondary outcomes
Recanalization Endpoint
Time frame: Intra-procedure
Recanalization Endpoint
Time frame: Intra-procedure
Recanalization Endpoint
Time frame: Intra-procedure
Recanalization Endpoint
Time frame: Intra-procedure
Recanalization Endpoint
Time frame: Intra-procedure
Clinical Endpoint
Time frame: 90 day
Safety Endpoint
Time frame: 24 (-8/+12) hours
Safety Endpoint
Time frame: Intra-procedure
Safety Endpoint
Time frame: Intra-procedure
Safety Endpoint
Time frame: During hospital admission
Safety Endpoint
Time frame: 90 days (±14 days) after the procedure.
Safety Endpoint
Time frame: Intra-procedure
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboaspiration catheter in people with Acute Ischemic Stroke, run by iVascular S.L.U. at 11 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 7 inclusion and 14 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Spain, Hungary. 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?
Recanalization Endpoint (time frame: Intra-procedure). 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 4 Nov 2026.