Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy (iCURE cSDH)

Kaneka

Status: Not yet enrolling

Conditions: cSDH; Chronic Subdural Hematomas; Chronic Subdural Hematoma

Treatments: Device: Neuro endovascular embolic coil

Study type: Observational

Funder types: Industry

Identifiers

NCT07214623

CLIN-002

Details and patient eligibility

About

All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre morbid mRS 0-3
• Chronic subdural symptomatic, requiring intervention

Exclusion criteria

• Acute subdural hematoma
• Intercranial mass other than subdural hematoma
• Females pregnant or breast feeding
• Compromised survival or inability to complete trial