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Clot-Removal procedure for severe strokes put to the test

NCT ID NCT03811769

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 looked at whether a procedure to remove large blood clots from the brain could help people who had a severe stroke. It included 335 adults with a large stroke who could be treated within 7 hours. The goal was to see if the procedure reduced disability compared to standard care. The study was stopped early, so results are limited.

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

335 people

The number who actually took part.

Started

Apr 2019

Finished

Aug 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Subject is ≥ 18 years old at inclusion (no upper age limit) 2. Clinical signs consistent with acute ischemic stroke with symptoms onset or TLKW ≤ 6.5 hours from randomization, or with negative FLAIR on MRI if TLSW is unknown, with treatment started within 7 hours. 3. Proven Large Ischemic Core defined as: ASPECT Score ≤ 5 on non-contrast CT or DWI-MRI, and in patients ≥ 80 years: ASPECT = 3 to 5 on non-contrast CT or DWI-MRI 4. Proved anterior circulation intracranial large vessel occlusion on CTA or MRA (intracranial ICA, M1, M1-M2). The MCA - M1 segment is defined as the first branch of the intracranial ICA which courses horizontally from its branching point off the ICA through the Sylvian fissure up to the first bifurcation distal to the lenticulo-striate arteries, in the Sylvian fissure. M2 is defined as the portions of the MCA distal to the first bifurcation or trifurcation, but prior to the second bifurcation. 5. Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form 6. Selection imaging performed ≤ 3 hours before randomization 7. Anticipated possibility to start the procedure (arterial access) within 30 minutes after randomization 8. Pre stroke mRS ≤ 1 9. Subjects receiving antiaggregant and/or anticoagulant agents (at any mode of administration) within the last 24 hours from screening are eligible for participation. 10. NIHSS \> 6 11. For patients for whom thrombolytic therapy, such as IV t-PA, is indicated, such treatment is initiated as soon as possible and within the accepted clinical guidelines as measured from stroke symptom onset. Exclusion criteria: 1. Known absence of vascular access. 2. Known contrast or endovascular product life-threatening allergy. 3. Female who is known to be pregnant or lactating at time of admission 4. Patient presents severe or fatal co-morbidities or life expectancy under 6 months that will likely interfere with the improvement or follow-up or that will render the procedure unlikely to benefit the patient. 5. Patient unable to present or be available for follow-up. 6. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations. 7. Evidence of vessel recanalization prior to randomization. 8. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment. 9. Current participation in another investigational drug study. 10. Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging. 11. Major patients under guardianship. 12. Blood glucose \< 50 mg/dL or \> 400 mg/dL 13. Cr \> 4.0 mg/dL, unless the patient is on dialysis 14. Platelet count \< 50000/uL 15. INR \> 3.0 or PTT \> 3 times upper limit of normal (ULN) Imaging Exclusion Criteria: 1. Isolated proximal cervical ICA occlusions or proximal cervical ICA occlusions with MCA-M1 or intracranial ICA occlusion requiring stent placement, and isolated M2 occlusions on the pre-randomization neuro-imaging 2. Evidence of intracranial hemorrhage on CT/MRI 3. Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in unstable access platform 4. High Suspicion of underlying intracranial stenosis on CTA/MRA/DSA 5. Suspected cerebral vascular disease (e.g. vasculitis) based on medical history and CTA/MRA/DSA 6. Presumed calcified Embolus or Intracranial Stenosis decompensation 7. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the stentriever device 8. Occlusions in multiple vascular territories (e.g.: bilateral anterior circulation, or anterior circulation/vertebrobasilar system) confirmed on CTA/MRA/DSA. 9. Significant mass effect with midline shift as confirmed on CT/MRI 10. Any ipsilateral cervical ICA lesion (Tandem), that requires stent placement

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hopital Gui De Chauliac

    Montpellier, 34295, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.