Acute Ischemic StrokeiNFLOW-5NCT07571954
Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy
A study testing Thromboaspiration catheter in people with Acute Ischemic Stroke, run by iVascular S.L.U. at 7 sites in 2 countries.
Trial summary
Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke 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
- 45 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 31 Aug 2026to 30 Nov 2027
- Phase
- Interventional
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 able to be treated (i.e., defined by groin puncture time) within 24 hours of symptom onset or last time seen well.
- Occlusion in a large or proximal medium vessel (M1, proximal M2, A2 or P2) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
- Baseline NIHSS score ≥ 6 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).
- France-specific inclusion criteria: As applicable under French law, subjects affiliated with a health social security scheme or equivalent.
Who cannot join
- 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.
- Severe allergy to contrast media.
- Women of child-bearing potential.
- 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).
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- Subjects with occlusions in multiple vessels.
- Subjects with cancer who have a life expectancy of less than 6 months.
- Pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.
- Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the subject may be included.
- Known or suspected cerebral vasculitis.
- Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
- Current participation in an interventional drug or device study that may confound the results of this study.
- Intracranial stenosis proximal to the occlusion.
- France-specific exclusion criteria: As applicable under French law, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of legal age who are the subject of a legal protection measure.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Spain5 sites
Hospital Clínico de Barcelona
Barcelona, Barcelona
Jordi Blasco, Dr, +34 936724711, clinica@ivascular.global
Jordi Blasco, Dr.
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Catalonia
Hospital Regional Universitario de Málaga Carlos Haya
Málaga, Andalusia
María Teresa Díaz, Dr., +34 936724711, clinica@ivascular.global
María Teresa Díaz, Dr.
Hospital Álvaro Cunqueiro
Vigo, Galicia
Carlos Manuel Rodriguez, Dr., +34 936724711, clinica@ivascular.global
Carlos Manuel Rodriguez, Dr.
Hospital Universitario Miguel Servet
Zaragoza, Aragon
María Rosa Barrena, +34 936724711, clinica@ivascular.global
María Rosa Barrena, Dr.
France2 sites
CHU Bordeaux (H Pellegrin)
Bordeaux
Xavier Barreau, Dr, +34 936724711, clinica@ivascular.global
Xavier Barreau, Dr.
CHU Lille
Lille
Nicolas Bricout, +34 936724711, clinica@ivascular.global
Nicolas Bricout, Dr.
About this study
Official title: Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the Instroke 5F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke.
Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke
Read the detailed description
This clinical investigation has been designed to evaluate the efficacy and safety of the iNstroke 5F aspiration catheter for its use in the treatment of LVO, with a view to comparing this product with standard therapy or with other similar products in a future pivotal clinical investigation.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Thromboaspiration catheter
- Keywords
- Stroke, Thromboaspiration, Ischemia
- 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 5F
| Study group | Role | What they receive |
|---|---|---|
| Thromboaspiration using iNstroke 5F aspiration catheter | Other | No comparator will be used as this is a traditional feasibility clinical investigation. The objective is to capture preliminary clinical performance, effectiveness and safety information to adequately plan an appropriate pivotal clinical investigation. Receives: Device: Thromboaspiration catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization Rate
Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever
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 posted7 May 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Nov 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
- 45 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
- NCT07571954
- Sponsor's protocol ID
- iNFLOW-5
- Acronym
- iNFLOW-5
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No