Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKazutaka Uchida
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
Cr >=1.8
Plt <50,000, PT-INR >2
Life expectancy <6 months
Trial design
Treatments tested in this trial
- Middle meningeal artery embolization
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kazutaka Uchida
Lead sponsor
Hyogo Medical University
Sponsor institution
Source ClinicalTrials.gov