Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT03811769
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03811769
Study Brief:
Protocol Section:
NCT03811769