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

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

Recruiting
18 years and older
All
Phase N/A
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Overview

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.

Eligibility

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

Study details
    Subdural Hematoma
    Subdural Hematoma
    Chronic

NCT07258069

Aesculap AG

13 May 2026

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