Overview
COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.
Eligibility
Inclusion Criteria:
- Age \>=18
- pre-mRS 0-3
- Hematoma thickness \>=10mm
- Having at least one risk factor Risk factor: Age \>=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score \>3, Preoperative volume \>=130ml, Preoperative midline shift \>=8mm, CT appearance (Homogeneous, laminar or separated)
Exclusion Criteria:
- Cr \>=1.8
- Plt \<50,000, PT-INR \>2
- Life expectancy \<6 months
