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RecruitingNCT06772740Updated Jul 17, 2026

Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

An interventional study of Middle meningeal artery embolization in Endovascular Treatment and Chronic Subdural Hematoma, sponsored by Kazutaka Uchida. Recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Kazutaka Uchida · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Endovascular Treatment
  • Chronic Subdural Hematoma
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In context

Hematoma, Subdural, Chronic

114 studies on the registry are indexed under Hematoma, Subdural, Chronic; 48 are open to participants now.

This study's planned enrollment of 600 is above the median of 164 across 87 interventional studies indexed under Hematoma, Subdural, Chronic.

Browse Hematoma, Subdural, Chronic studies →

Lead sponsor

This is the only study on the registry with Kazutaka Uchida as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Cr >=1.8
  2. Plt \<50,000, PT-INR >2
  3. Life expectancy \<6 months
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Conventional treatments with middle meningeal artery embolization

    Procedure: Middle meningeal artery embolization

  • No intervention
    Conventional treatments alone

Interventions

  • ProcedureMiddle meningeal artery embolization

    Middle meningeal artery embolization within 7 days after randomization

06

What researchers measure

Primary outcomes

  1. Rate of recurrence of chronic subdural hematoma

    Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation.

    Time frame: 6 months after randomization

07

Study locations

1 of 1 sites recruiting
  • Hyogo Medical University
    Nishinomiya, Hyōgo 663-8501, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06772740
Lead sponsor
Kazutaka Uchida
Responsible party
Kazutaka Uchida (Associate Professor (Stroke Center), Hyogo Medical University) — Sponsor-investigator
First posted
Jan 14, 2025
Start date
Dec 23, 2024
Primary completion
Aug 31, 2027 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Jul 17, 2026

Study contacts

Kazutaka Uchida, MD, PhD
Contact
fu-sakakibara@hyo-med.ac.jp
81+798-45-6458

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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