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Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

RecruitingNA

Sponsor: Kazutaka Uchida

Conditions: Endovascular Treatment, Chronic Subdural Hematoma

Interventions: Middle meningeal artery embolization

Countries: Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Nishinomiya, Hyōgo, Japan