Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

Kazutaka Uchida

Status: Enrolling

Conditions: Endovascular Treatment; Chronic Subdural Hematoma

Treatments: Procedure: Middle meningeal artery embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT06772740

R000063204

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Conventional treatments with middle meningeal artery embolization

Experimental group

Treatment:

Procedure: Middle meningeal artery embolization

Conventional treatments alone

No Intervention group