Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

Not Applicable

Recruiting

• Conditions: Endovascular Treatment; Chronic Subdural Hematoma

• Registration Number: NCT06772740
• Lead Sponsor: Kazutaka Uchida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-23
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-28
• Primary Completion: 2027-08-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of recurrence of chronic subdural hematoma	6 months after randomization	Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation.

Trial Locations

Locations (1)

Hyogo Medical University; 🇯🇵 Nishinomiya, Hyogo, Japan