Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
Recruiting
N/A
Interventional Study
Endovascular Treatment
Chronic Subdural Hematoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- Kazutaka Uchida · Other
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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.
Trial Locations
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Eligibility Criteria
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 (Homo…
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