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New catheter aims to suck out stroke clots fast

NCT ID NCT07376447

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 catheter, designed to remove blood clots from the brain in people having an acute ischemic stroke. About 160 participants will undergo a procedure where the catheter is used to suction out the clot. The main goal is to see how often the device successfully restores blood flow within three attempts, either alone or with a stent retriever.

What this could mean

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

Active substance
iNstroke 6F and 4F thromboaspiration catheter
What this could lead to
If successful, this device could provide a reliable way to quickly restore blood flow in stroke patients, potentially reducing brain damage and improving recovery.
What could go wrong
This is a single-arm study with no comparison group, so results may be less conclusive. The device may not work for all clot types or could cause complications like 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 160 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 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: 1. Patients ≥ 18 years of age. 2. Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW). 3. Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3). 4. Baseline NIHSS score ≥6 assessed before the procedure. 5. Pre-morbid \[xB13.1\]stroke baseline mRS ≤ 2. 6. Subjects with an ASPECTS ≥ 6. 7. Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data. 8. As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites). Exclusion Criteria: 1. 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. 2. Severe allergy to contrast media. 3. As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure. 4. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection. 5. Multiple Intracranial Occlusions 6. Known medical history of thrombocytopenia (Platelets \<100,000). 7. Presence of intracerebral hemorrhage. 8. Significant mass effect and/or midline shift. 9. Evidence of intracranial tumor (except small meningioma). 10. Intracranial stenosis proximal to the occlusion. 11. 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 patient may be included. 12. Known or suspected cerebral vasculitis. 13. Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) \<30 mL/min. 14. Current participation in an interventional drug or device study that may confound the results of this study.

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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 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

  • APHP Pitié Salpétrière

    Paris, France

    Contact Email: •••••@•••••

  • CHU Bordeaux (H Pellegrin)

    Bordeaux, France

    Contact Email: •••••@•••••

  • CHU Brest

    Brest, France

    Contact Email: •••••@•••••

  • CHU Lille

    Lille, France

    Contact Email: •••••@•••••

  • CHU Nancy

    Nancy, France

    Contact Email: •••••@•••••

  • CHU Strasbourg

    Strasbourg, France

    Contact Email: •••••@•••••

  • Klinikum Bremen Mitte

    Bremen, Germany

    Contact Email: •••••@•••••

  • Klinikum Nürnberg

    Nuremberg, Germany

    Contact Email: •••••@•••••

  • Knappschaft Kliniken

    Dortmund, Germany

    Contact Email: •••••@•••••

  • UKE Hamburg

    Hamburg, Germany

    Contact Email: •••••@•••••

  • Universität zu Köln

    Cologne, Germany

    Contact Email: •••••@•••••

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