Study of the Effectiveness and Safety of Embolization of the Middle Meningeal Artery Using Non-adhesive Materials SQUID 12 and SQUID 18 in the Treatment of Patients With Chronic Resistant Migraine

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age35-59
SponsorVedanta University Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • liquid embolic agent SQUID 12, liquid embolic agent SQUID 18

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators