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New catheter could improve stroke recovery by clearing clots faster

NCT ID NCT06370182

Disease control Sponsor: Anaconda Biomed S.L. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special catheter designed to help remove large blood clots in the brain during a stroke. About 327 adults aged 22 to 85 who have a disabling stroke will be treated within 16 hours of symptoms. The goal is to see if the device safely restores blood flow in one pass, reducing brain damage and improving outcomes.

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 327 people

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

Started

Sep 2024

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

22 to 85 years

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.

Key Inclusion Criteria: Subjects meeting all inclusion criteria will be considered for enrollment in the study. 1. Age 22 to 85 years. 2. Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative). 3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia. 4. Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points. 5. Pre-ictal mRS score of 0,1 or 2. 6. Treatable within 16 hours of symptom onset, defined as point in time when the subject was last observed to be asymptomatic; treatment start is defined by arterial puncture time. 7. If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay. 8. Occlusion (eTICI ≤ 1 flow) of the terminal carotid artery, middle cerebral artery M1 segment or, dominant or proximal M2 segment, indicated for mechanical thrombectomy, confirmed with conventional angiography or CTA/MRA. 9. Imaging criteria: * Perfusion weighted criterion: volume of diffusion restriction visually assessed ≤ 50 mL on CTP/MRP, or * CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT/DWI-MRI. (Inclusion of subjects with ASPECTS 5 is permitted at centers performing scoring on MRI) 10. The subject is indicated for a neurovascular thrombectomy procedure with an approved stent retriever per its Instructions for Use. Key Exclusion Criteria: Subjects who meet any of the exclusion criteria will be ineligible for participation in the study. The following exclusion criteria will be assessed pre-operatively: 1. Subject was diagnosed with a stroke in the past year. 2. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. 3. Known hemorrhagic diathesis, coagulation factor deficiency, oral anticoagulant therapy with antivitamin K, with INR \>3.0, or thrombocytopenia - baseline platelet count \< 50,000 platelets/mL. 4. Known baseline glucose of \<50 mg/dL or \>400 mg/dL. 5. Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg). 6. Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year. 7. Known cancer with metastases. 8. History of life-threatening allergy (more than rash) to contrast medium. 9. Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) \<30 mL/min. 10. Subject is a current user or has a recent history of cocaine \&/or heroin use. 11. Known pregnancy and/or lactating female. 12. Subject is participating in a concurrent study involving an investigational drug or device that would impact the primary endpoint of this study. 13. Subject is unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas, etc.) 14. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed). 15. Significant mass effect with midline shift. 16. Evidence of intracranial tumor (except asymptomatic meningioma of ≤ 2cm in diameter). 17. Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis. 18. History of preexisting stent proximal to or at the occlusion site that may preclude safe deployment or recovery of the stent retriever. 19. Vessel tortuosity too difficult to allow endovascular access of the intracranial ICA per investigator judgement. Indicators of vessel tortuosity include but are not limited to the presence of carotid loops and type 3 aortic arches.

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Conditions

The condition(s) this trial relates to.

ischemic stroke large artery stroke

As listed by the trial registrant

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

Acute ischemic stroke from large vessel occlusion

How to take part

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

  1. The places running it

    22 sites in 5 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Advocate Health

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Aurora St. Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Aydin University Hospital

    RECRUITING

    Istanbul, 34295, Turkey (Türkiye)

  • Baptist Health Medical Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Centre Hospitalier Universitaire de Montpellier

    RECRUITING

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire de Toulouse

    RECRUITING

    Toulouse, 40031, France

  • Fondation Rothschild

    RECRUITING

    Paris, 75019, France

  • Grady Memorial Hospital, Emory

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Foch

    RECRUITING

    Suresnes, 92150, France

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, 33011, Spain

  • Hospital Universitario Vall D'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Virgen de la Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Semmelweis University Hospital

    RECRUITING

    Budapest, 1145, Hungary

  • University of Buffalo Neurosurgery

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Pittsburg Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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