Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural He… (NCT07258069) | Clinical Trial Compass
RecruitingNot Applicable
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
Japan178 participantsStarted 2026-04-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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