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NCT Number: NCT06772740

Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

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.

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Key information

Conditions

Endovascular Treatment Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Chronic Subdural Hematoma Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hyogo Medical University

Nishinomiya, Hyōgo, 663-8501, Japan

Location status: Recruiting

Location contact

Kazutaka Uchida, MD, PhD

CONTACT

[email protected]

+81-798-45-6458

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >=18
  • pre-mRS 0-3
  • Hematoma thickness >=10mm
  • 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

  • Cr >=1.8
  • Plt <50,000, PT-INR >2
  • Life expectancy <6 months

Treatment and study plan

Middle Meningeal Artery Embolization

Procedure

Middle meningeal artery embolization within 7 days after randomization

Primary outcomes

  1. Rate of recurrence of chronic subdural hematoma

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kazutaka Uchida, MD, PhD

CONTACT

[email protected]

81+798-45-6458

Sponsors and collaborators

Lead sponsor

Kazutaka Uchida

Other

Registry information

Official study title

Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jan 14, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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