To evaluate the effectiveness and safety of middle meningeal artery (MMA) embolization using non-adhesive materials SQUID 12 and SQUID 18 as a treatment method for patients with chronic resistant migraine.
The patient has read, understood, signed, and dated the Patient Information Sheet with the informed consent form.
The patient is aged between 35 and 59 years inclusive at the time of signing the Patient Information Sheet with the informed consent form.
The diagnosis of "chronic migraine" according to the clinical guidelines on migraine by the Ministry of Health of the Russian Federation (2021) / ICD-10 (2018), established at least 12 months before screening.
Resistant nature of the migraine, determined by the doctor using the criteria of the European Headache Federation (EHF, 2020), established at least 6 months before screening.
The patient has contraindications to undergoing embolization of the middle meningeal artery based on the medical history, results of examinations, and laboratory tests conducted during screening.
Allergic reactions to contrast agents used during procedures before/during the embolization procedure and associated procedures.
The patient has a history of cerebral vascular malformations, arteriovenous malformations, brain aneurysms, brain tumors, hydrocephalus, arachnoiditis, cerebrospinal fluid circulation disorders, craniovertebral junction anomalies, platybasia, skull base deformities, severe traumatic brain injuries, stenosis, and occlusion of pre-cerebral arteries.
The patient has a history of skull base fractures and consequences of skull base fractures, history of neurosurgical operations.
Single group
liquid embolic agent SQUID 12, liquid embolic agent SQUID 18
DeviceTotal endovascular embolization of the frontal and parietal branches (less often the occipital branch) of the middle meningeal artery (MMA) with its complete devascularization. In the case of unilateral pain localization, ipsilateral MMA embolization will be performed; in the case of bilateral pain localization, total embolization of both MMA branches will be performed.
number of migraine days
Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 3 months (12 weeks) post-surgery
The number of migraine days after surgery
The number of migraine days over the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
The average number of migraine days
The average number of migraine days over a 4-week period, calculated for the preceding 12-week period, assessed at visits 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
The number of headache days over the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
The number of headache days over the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
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