Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Japan
Hyogo Medical University
RECRUITING
Nishinomiya
Contact Information
Primary
Kazutaka Uchida, MD, PhD
fu-sakakibara@hyo-med.ac.jp
81+798-45-6458
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 600
Treatments
Experimental: Conventional treatments with middle meningeal artery embolization
No_intervention: Conventional treatments alone
Related Therapeutic Areas
Sponsors
Leads: Kazutaka Uchida