Middle Meningeal Artery embolization: Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline, in number of migraine days — over 28 days post study intervention
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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