MMA Embolization for Refractory Chronic Migraine
Feasibility Study to Evaluate the Initial Safety and Effectiveness of TRUFILL n-BCA Liquid Embolic System in Middle Meningeal Artery Embolization for the Preventive Treatment of Refractory Chronic Migraine
Cerenovus, Part of DePuy Synthes Products, Inc.
70 participants
Apr 23, 2025
INTERVENTIONAL
Conditions
Summary
This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine.
Eligibility
Inclusion Criteria5
- Patient is between 18 and 65 years of age (inclusive) at the time of consent.
- Age of onset of Chronic Migraine ≤ 64 years.
- Age of onset of migraine diagnosis \< 50 years.
- Patient has a current diagnosis of refractory migraine.
- Patient has a current diagnosis of Chronic migraine.
Exclusion Criteria2
- \. Patients with a history for the last 2 years of other types of headache. 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.
- \. Women who are pregnant, lactating, or who are of childbearing age. 7. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required.
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Interventions
Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06735833