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Not yet recruitingNCT07571954iNFLOW-5Updated Nov 5, 2026

Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy

An interventional study of Thromboaspiration catheter in Acute Ischemic Stroke, sponsored by iVascular S.L.U.. Not yet recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by iVascular S.L.U. · Not applicable, Interventional, and Treatment

Updated Nov 5, 2026Start date movedPrimary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Stroke
  • Thromboaspiration
  • Ischemia
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 45 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

iVascular S.L.U. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.

Browse iVascular S.L.U. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Severe comorbidity and/or shortened 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 .
  • Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
  • Medical history of thrombocytopenia ( \<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.
  • 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 (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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Other
    Thromboaspiration using iNstroke 5F aspiration catheter

    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.

    Device: Thromboaspiration catheter

Interventions

  • DeviceThromboaspiration catheter

    Patients to undergo thromboaspiration with iNstroke 5F

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Intra-procedure

07

Study locations

7 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

Of 81 industry-sponsored interventional studies with no phase under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 6 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Aug 2026 → Nov 2026 and primary completion Jul 2027 → May 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2026
First posted
May 7, 2026
StartEst.
Nov 2026was Aug 2026
Primary completionEst.
May 31, 2027was Jul 2027
CompletionEst.
Nov 30, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 31, 2026→Nov 2026
Nov 5, 2026
Primary completion
Jul 31, 2027→May 31, 2027
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Start date Aug 31, 2026→Nov 2026
    Primary completion Jul 31, 2027→May 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07571954
Lead sponsor
iVascular S.L.U.
Responsible party
Sponsor
First posted
May 7, 2026
Start date
Nov 2026 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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