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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT05539404
Eligibility Criteria:
Inclusion Criteria:
* Patients experiencing an acute ischemic stroke related to an anterior proximal large vessel occlusion (ICA/M1/Tandem) on MR or CT-angiography evolving for less than 24 hours from last known to be well. For patients experiencing a wake-up stroke or a stroke of unknown onset the mid-point between last seen well and symptoms discovery + the delay between symptoms discovery to randomization, will be used to calculate the delay between symptom onset to randomization.
* On baseline imaging (MRI Diffusion Weighted Imaging/Perfusion Weighted Imaging or CTP) L.P. profile defined by a Large Core \> 70 mL, and a MM ratio\>1.4 using RAPID software.
* Delay between end of imaging and randomization \<90 min.
* Expected delay between end of imaging and femoral puncture \< 60 min
* Best medical treatment including IV thrombolysis if indicated
* Surrogate decision maker's consent or emergency inclusion form.
* Affiliated person or beneficiary of a social security scheme.
Exclusion Criteria:
* Pre-Stroke mRS \>1.
* Other serious advanced or terminal illness or life expectancy is estimated to be less than 6 months.
* Pre-existing medical, neurological or psychiatric condition that would confound the neurological or functional evaluation.
* Pregnancy and breastfeeding
* Inability to undergo contrast brain perfusion MR or CT.
* Technically inadequate perfusion imaging precluding L.P. profile assessment
* Occlusion in multiple proximal vascular site territories (eg. bilateral anterior circulation occlusion or anterior + posterior circulation occlusions).
* Known allergy to iodine precluding EVT.
* Vessel anatomy or tortuosity precluding EVT.
* Patient under judicial protection.
* Participation in another interventional or therapeutic study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05539404
Study Brief:
Protocol Section:
NCT05539404