Minor Stroke Therapy Evaluation

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jan 7, 2019

Keywords

ClinConnect Summary

The Minor Stroke Therapy Evaluation trial is studying how to treat patients who have had a minor stroke caused by a blockage in a major brain artery. While standard treatments exist for more severe strokes, this trial aims to find out if certain patients with milder symptoms can benefit from a procedure called endovascular therapy (EVT), which involves removing the blockage from the artery. This is important because even patients with milder symptoms may have significant blockages that could lead to worse outcomes if left untreated.

To be eligible for the trial, participants need to be at least 18 years old and have had a stroke within the last 23 hours, with specific mild symptoms measured by a scoring system. They must also have a certain type of blockage confirmed by imaging tests. If someone joins the trial, they can expect to receive the latest care and be closely monitored throughout the process. This study is currently recruiting participants, so it's a great opportunity for those who meet the criteria and want to contribute to stroke research.

Gender

ALL

Eligibility 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