Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

Recruiting now · Not applicable

Conditions studied: Endovascular Treatment, Chronic Subdural Hematoma

In brief

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.

Key facts

Study ID

NCT06772740

Run by

Kazutaka Uchida

People needed

600

Starts

2024-12-23

Expected to finish

2029-03-31

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Cr >=1.8
• Plt <50,000, PT-INR >2
• Life expectancy <6 months

Where it is running

• Hyogo Medical University — Nishinomiya, Hyōgo, Japan (enrolling)

Full record on ClinicalTrials.gov

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