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New catheter aims to clear small brain clots in stroke patients

NCT ID NCT07357285

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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the iNstroke 4F catheter, designed to remove blood clots from small blood vessels deep in the brain after a stroke. About 57 adults who have had a stroke within the past 24 hours will receive this treatment. The goal is to see if the catheter can safely restore blood flow and improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iNstroke 4F thromboaspiration catheter
What this could lead to
If successful, this catheter could offer a new way to treat strokes caused by clots in smaller brain vessels, potentially improving recovery for many patients.
What could go wrong
This is a small, early-stage study with no comparison group, so results may not apply broadly. The procedure carries risks like bleeding or vessel damage.

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 57 people

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

Started

Nov 2025

Expected to finish

Aug 2026

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 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). Exclusion Criteria: * 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. * 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.

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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

    11 sites in 3 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

  • Hospital Clínico Universitario Virgen de Arrixaca

    RECRUITING

    Murcia, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario La Paz

    NOT_YET_RECRUITING

    Madrid, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario de Getafe

    NOT_YET_RECRUITING

    Madrid, Spain

    Contact Email: •••••@•••••

  • Klinikum Marburg

    NOT_YET_RECRUITING

    Marburg, Germany

    Contact Email: •••••@•••••

  • Klinikum Nürnberg

    NOT_YET_RECRUITING

    Nuremberg, Germany

    Contact Email: •••••@•••••

  • Knappschaftskrankenhaus Recklinghausen

    RECRUITING

    Recklinghausen, Germany

    Contact Email: •••••@•••••

  • Semmelweis University Center

    RECRUITING

    Budapest, Hungary

    Contact Email: •••••@•••••

  • Universitätsklinikum Bonn

    NOT_YET_RECRUITING

    Bonn, Germany

    Contact Email: •••••@•••••

  • Universitätsklinikum Schleswig-Holstein

    NOT_YET_RECRUITING

    Kiel, Germany

    Contact Email: •••••@•••••

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