Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)

Aesculap

Status: Not yet enrolling

Conditions: Subdural Hematoma; Subdural Hematoma, Chronic

Treatments: Device: Histoacryl®

Study type: Observational

Funder types: Industry

Identifiers

NCT07258069

AAG-O-H-25118

Details and patient eligibility

About

The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or older
• Confirmed diagnosis of chronic subdural hematoma (CSDH) or recurrent subdural hematoma (SDH)
• Completed documented informed consent
• Willingness and presumed capability to participate in follow-up visits for up to 6 months (180±30 days)

Exclusion criteria

• Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment
• Need craniotomy
• Any sign of anatomical variations that could make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses)
• Coagulation dysfunction with INR>1.8 and/or platelet count <80x109 /L
• Allergic reactions to essential medicines to do angiography
• Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
• Participation in another clinical trial