Clot-Removal procedure for severe strokes put to the test
NCT ID NCT03811769
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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335 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Aug 2023
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Hopital Gui De Chauliac
Montpellier, 34295, France
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Other studies related to the condition(s) this trial covers.
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