Evaluating treatment for minor strokes with mechanical thrombectomy
Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours
This study is testing if a procedure called mechanical thrombectomy can help people with minor strokes feel better compared to just using standard medical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 824 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT03796468 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of mechanical thrombectomy in patients experiencing minor to mild stroke symptoms caused by proximal intracranial arterial occlusions. The study aims to determine the outcomes of patients with a low NIHSS score who may benefit from this intervention, as current guidelines primarily focus on those with more severe symptoms. Participants will receive either best medical therapy or mechanical thrombectomy, with the goal of improving neurological outcomes within a 24-hour treatment window. The trial is designed to fill a gap in existing research regarding the management of minor stroke cases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present with minor stroke symptoms and have a confirmed proximal large vessel occlusion.
Not a fit: Patients with severe stroke symptoms or those who do not meet the eligibility criteria, such as a high NIHSS score, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with minor strokes, potentially improving their recovery and reducing long-term disability.
How similar studies have performed: While mechanical thrombectomy has shown success in treating major strokes, this approach for minor strokes is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is ≥ 18 years old at inclusion (no upper age limit) * Clinical signs consistent with acute ischemic stroke with time last known well (TLKW) ≤ 23h at randomization (With the goal of remaining within 24 hours from TLKW til treatment) * Patients NIHSS 0-5 at the time of randomization * ASPECT ≥ 6 on non-contrast CT or Diffusion Weighted Imaging (DWI)-MRI * Ischemic Stroke confirmed with cerebral imaging or normal imaging with suspected ischemic stroke * Proved anterior circulation intracranial large vessel occlusion on CTA or Magnetic resonance angiography (MRA) (ICA, M1, M1-M2, with or without cervical lesion (Tandem)) * Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for emergent consent. * Anticipated possibility to start the procedure (arterial access) within 60 minutes after randomization * Pre stroke mRS ≤ 1 * For Drip and Ship patients : new imaging performed again on inclusion center if first imaging performed \> 1 hour before randomization. Exclusion Criteria: General Exclusion Criteria * Anticipated impossibility to start the procedure (arterial access) within 60 minutes after randomization * Known absence of vascular access * Known contrast or endovascular product life-threatening allergy * Female who is known to be pregnant or lactating at time of admission * Patient presents severe or fatal co-morbidities or Life expectancy under 6 months that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. * Patient unable to present or be available for follow-up * Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations * Evidence of vessel recanalization prior to randomization * Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment. * Current participation in another investigational drug study * Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging * Major patients under guardianship Imaging Exclusion Criteria * Evidence of intracranial hemorrhage on CT/MRI * Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in unstable access platform * High Suspicion of underlying intracranial stenosis on CTA/MRA * Suspected cerebral vascular disease (e.g. vasculitis) based on medical history and CTA/MRA * Presumed calcified Embolus or Intracranial Stenosis decompensation * Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the stentriever device * Occlusions in multiple vascular territories (e.g.: bilateral anterior circulation, or anterior circulation/vertebrobasilar system) on CTA/MRA * Significant mass effect with midline shift as confirmed on CT/MRI
Where this trial is running
Montpellier
- Hopital Gui De Chauliac — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Vincent COSTALAT, PU-PH — Hôpital Gui de Chauliac
- Study coordinator: Caroline ARQUIZAN, PH
- Email: c-arquizan@chu-montpellier.fr
- Phone: 4 67 33 75 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.