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New catheter aims to quickly clear Stroke-Causing clots

NCT ID NCT07571954

Disease control Sponsor: iVascular S.L.U. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the iNstroke 5F catheter to remove blood clots in people having an acute ischemic stroke. The goal is to see if it can safely restore blood flow to the brain within 24 hours of symptoms starting. About 45 adults with moderate to severe strokes will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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. Exclusion Criteria: * 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). * 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.

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Conditions

The condition(s) this trial relates to.

ischemic disease ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Bordeaux (H Pellegrin)

    Bordeaux, France

    Contact Email: •••••@•••••

  • CHU Lille

    Lille, France

    Contact Email: •••••@•••••

  • Hospital Clínico de Barcelona

    Barcelona, Barcelona, Spain

    Contact Email: •••••@•••••

  • Hospital Regional Universitario de Málaga Carlos Haya

    Málaga, Andalusia, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario Bellvitge

    L'Hospitalet de Llobregat, Catalonia, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, Spain

    Contact Email: •••••@•••••

  • Hospital Álvaro Cunqueiro

    Vigo, Galicia, Spain

    Contact Email: •••••@•••••

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