Actively Recruiting
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
Led by Vedanta University Clinic · Updated on 2025-02-26
30
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has read, understood, and signed the informed consent form.
- Age between 35 and 59 years inclusive at the time of consent.
- Diagnosis of chronic migraine established at least 12 months before screening.
- Resistant migraine diagnosed at least 6 months before screening based on European Headache Federation criteria.
- At least 14 headache days in the 28-day screening period, with at least 8 migraine days.
- History of migraine resistant to pharmacological and non-pharmacological treatments.
- Maximum headache intensity of 5 or higher on a 10-point scale during migraine days in screening.
- No positive effect from previous botulinum toxin therapy in migraine treatment.
- Consent to use adequate contraceptive methods and not serve as egg/sperm donor during study (for women of reproductive potential and men).
You will not qualify if you...
- Contraindications to middle meningeal artery embolization.
- Allergic reactions to contrast agents used during embolization.
- History of cerebral vascular malformations, aneurysms, tumors, hydrocephalus, arachnoiditis, cerebrospinal fluid disorders, craniovertebral anomalies, severe brain injuries, or artery stenosis/occlusion.
- History of skull base fractures or neurosurgical operations.
- Mental illness affecting participation or safety, including depression.
- History of hyperthyroidism, diabetes, or other endocrine disorders affecting study participation.
- History of drug addiction, alcoholism, or medication abuse.
- Medication-induced headache within 3 months before screening.
- Other types of chronic headache within 12 months before screening.
- Inability to distinguish migraine from other headaches.
- Migraine complications such as status migrainosus or persistent aura.
- BMI below 18.5 or above 39.9 kg/m².
- Migraine onset after age 50.
- Presence of metabolic syndrome or cachexia.
- Severe cardiovascular diseases or uncontrolled hypertension.
- Varicose veins or history of vein thrombosis.
- Ischemic heart disease or atherosclerosis.
- Stenotic atherosclerosis of brachiocephalic arteries.
- History of acute cerebrovascular accident.
- Pregnancy or plans to become pregnant within 3 months.
- Atrial fibrillation or heart surgeries.
- Blood clotting disorders or antiphospholipid syndrome.
- Use of anticoagulants less than 5 days before procedure.
- Uncontrolled bronchial asthma or severe COPD.
- Renal insufficiency or history thereof.
- Liver insufficiency or elevated liver enzymes.
- Generalized pain syndrome or fibromyalgia.
- Use of combined oral contraceptives with history of thrombosis.
- History of epilepsy or neurological conditions other than migraine.
- Positive tests or history of HIV, hepatitis B or C, or syphilis.
- Malignant neoplasms within 5 years or suspected cancer.
- Other serious medical or psychological conditions interfering with study.
- Participation in other interventional clinical trials within 30 days before screening.
- Inability or unwillingness to comply with study procedures.
- Employees of the study medical institution or sponsor, their family or dependents.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vedanta University Clinic
Bishkek, Bishkek, Kyrgyzstan, 720054
Actively Recruiting
Research Team
A
Andrey E Petrov, MD, PhD
CONTACT
A
Andrey S Dakovskiy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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