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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT03796468
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03796468
Study Brief:
Protocol Section:
NCT03796468