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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT07291427
Eligibility Criteria:
Inclusion criteria:
* Age ≥ 18
* Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed.
* A clinical decision has been made to use coiling and/or embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study.
* Signed informed consent obtained by patient or Legal Authorized Representative (LAR)
Exclusion criteria:
* Primary acute SDH
* Prior MMAE in target territory
* Premorbid mRS \> 3
* Common carotid stenosis \>70% or prior carotid stent placement
* Significant medical contraindication to angiography (kidney failure/disease)
* Anatomical variations that would make MMA embolization difficult or unsafe
* Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints
* Pregnancy
* Life expectancy ≤ 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07291427
Study Brief:
Protocol Section:
NCT07291427