MMA Embolization for Refractory Chronic Migraine

ID#: NCT06735833

Age: 18 - 65 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 28, 2025

End Date: December 29, 2028

Contact Information:
Study Contact
2165439491
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: 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 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.

6. 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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