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Recruiting NCT06772740

Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

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Trial Parameters

Condition Endovascular Treatment
Sponsor Kazutaka Uchida
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-12-23
Completion 2027-08-31
Interventions
Middle meningeal artery embolization

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Brief Summary

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 Criteria

Inclusion Criteria: 1. Age \>=18 2. pre-mRS 0-3 3. Hematoma thickness \>=10mm 4. 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: 1. Cr \>=1.8 2. Plt \<50,000, PT-INR \>2 3. Life expectancy \<6 months

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