Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine. (FAST-EM-2)

Inclusion Criteria:

1. Age 18~80 years old (inclusive), regardless of gender.
2. Voluntary written informed consent.
3. Migraine diagnosed by neurologists/pain specialists according to the current International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria for migraine with or without aura.
4. Migraine attack frequency of no less than 4 days per month within one month prior to enrollment.
5. History of pharmacotherapy for migraine prophylaxis or treatment for at least 6 months.

Exclusion Criteria:

1. Findings on cerebral angiography indicating secondary headache due to intracranial vascular disorders, including dural arteriovenous fistula, arteriovenous malformation, venous malformation, or other relevant cerebrovascular lesions; Moyamoya disease; or high-risk vascular anatomical variants unsuitable for safe vascular access or contraindicating MMA embolization.
2. Complicated with cervical spondylosis and secondary headache of otogenic, rhinogenic, odontogenic origin; patients with a history of trigeminal autonomic cephalalgias; headache with other definite etiologies or secondary headache;
3. Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions;
4. Patients planning to undergo surgery within 90 days;
5. Patients with a life expectancy of less than 12 months;
6. Patients with a definite history of contrast media allergy;
7. Patients with a history of opioid addiction;
8. Breastfeeding or pregnant women, or patients with fertility plans within half a year;
9. Subjects who participated in other clinical trials of drugs or medical devices before enrollment and did not reach the time limit of the primary study endpoint;
10. Unable to understand headache-related assessment data such as headache diaries and requiring assistance from others to complete them;
11. Patients with poor compliance judged by the investigator and unable to complete the study as required;
12. Patients with a definite history of allergy to embolization materials such as nitinol alloy and/or cobalt-based alloy, platinum-tungsten alloy, etc.;
13. Subjects with other comorbidities that restrict their participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the study;
14. Other conditions in which the investigator considers the patient inappropriate to participate in this study.