Minor Stroke Therapy Evaluation (NCT03796468) | Clinical Trial Compass
UnknownNot Applicable
Minor Stroke Therapy Evaluation
France824 participantsStarted 2019-04-10
Plain-language summary
Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4.
The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.
Who can participate
Age range18 Years – 100 Years
SexALL
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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 e…