Large Stroke Therapy Evaluation (LASTE)

This is an interventional other trial for Stroke focused on measuring Mechanical thrombectomy, Stroke, Proximal intracranial arterial occlusions, Large vessel occlusion Read More

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 time last known well (TLKW) ≤ 6.5 h from randomization (With the goal of remaining within 7 hours from TLKW till treatment), or with negative FLAIR on MRI, if TLKW is unknown

3. Proven Large Ischemic Core defined as: ASPECT Score 0 to 5 on non-contrast CT or Diffusion Weighted Imaging (DWI)-MRI. In patients ≥ 80 years : ASPECT score 4 or 5.

   (ASPECTS on MRI will be calculated in the following way: an ASPECTS region will considered to be affected if > 30% of its area demonstrates restricted diffusion)

4. Proved anterior circulation intracranial large vessel occlusion on CTA or MRA (intracranial ICA, M1, M1-M2)
5. 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
6. Selection imaging performed maximum 3 hours from 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

General Exclusion Criteria:

1. Anticipated impossibility to start the procedure (arterial access) within 30 minutes after randomization.
2. Known absence of vascular access.
3. Known contrast or endovascular product life-threatening allergy.
4. Female who is known to be pregnant or lactating at time of admission
5. 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.
6. Patient unable to present or be available for follow-up.
7. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
8. Evidence of vessel recanalization prior to randomization.
9. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
10. Current participation in another investigational drug study.
11. Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging.
12. Major patients under guardianship.

Imaging Exclusion Criteria:

1. Evidence of intracranial haemorrhage on CT/MRI
2. Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in unstable access platform
3. High Suspicion of underlying intracranial stenosis on CTA/MRA/digital subtraction angiography (DSA)
4. Suspected cerebral vascular disease (e.g. vasculitis) based on medical history and CTA/MRA/DSA
5. Presumed calcified Embolus or Intracranial Stenosis decompensation
6. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the stentriever device
7. Occlusions in multiple vascular territories (e.g.: bilateral anterior circulation, or anterior circulation/vertebrobasilar system) confirmed on CTA/MRA/DSA.
8. Significant mass effect with midline shift as confirmed on CT/MRI
9. Any cervical ICA lesion (Tandem), that requires stent placement
10. Isolated proximal cervical ICA occlusions