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

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.

Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:

1. Patient is between 18 and 65 years of age (inclusive) at the time of consent
2. Age of onset of Chronic Migraine <= 64 years
3. Age of onset of migraine diagnosis < 50 years
4. Patient has a current diagnosis of refractory migraine
5. Patient has a current diagnosis of Chronic migraine

Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:

1. Patients with a history for the last 2 years of other primary headache types, or secondary headache types except medication overuse headache
2. Patients with diagnosis of hemiplegic migraine or migrainous infarct
3. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc
4. Women who are pregnant, lactating, or who are of childbearing age
5. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Participants in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required