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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT04555460
Eligibility Criteria:
Inclusion Criteria:
* A National Institutes of Health Stroke Scale score ≥16
* A score ≥1 for item 1a (level of consciousness)
* Brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory
* Diffusion-weighted imaging infarct volume \>150cm3
Exclusion Criteria:
* Prestroke modified Rankin score score ≥2
* Prestroke score on the Barthel Index \<95
* Score on the Glasgow Coma Scale \<6
* Both pupils fixed and dilated
* Any other coincidental brain lesion that might affect outcome
* Plasminogen activator in the 12 h before randomisation
* Space-occupying hemorrhagic transformation of the infarct
* Pregnancy
* Life expectancy \<3 years
* Other serious illness that might affect outcome
* Known coagulopathy or systemic bleeding disorder
* Contraindication for anesthesia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04555460
Study Brief:
Protocol Section:
NCT04555460