Status:
COMPLETED
Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine
Lead Sponsor:
The Affiliated Hospital Of Guizhou Medical University
Conditions:
Migraine
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objective...
Detailed Description
This study is a single-arm, self-controlled, open-label, single-center clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine s...
Eligibility Criteria
Inclusion
- Inclusion criteria：
- Voluntary written informed consent.
- Age 18\~80 years old (inclusive), regardless of gender.
- Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition
- Patients with intractable migraine or refractory headache with migraine duration of more than 3 months and recurring migraine in the past 90 days before screening.
- Patients who take two or more drugs are not satisfied with the therapeutic effect, the side effects of drug treatment are difficult to tolerate or have contraindications.
- Headache frequency should be confirmed within 30 days before screening.
- Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation.
- Exclusion criteria：
- Patients with cervical spondylosis and secondary headaches such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache, other definite causes of headache, or secondary headache.
- Patients without suitable vascular access.
- Patients scheduled for surgery within 90 days.
- The life expectancy of patients is less than 12 months.
- History of contrast agent allergy.
- Lactating or pregnant women, or patients with a fertility plan within 1 year.
- The clinical status of the patient was extremely poor, with an mRS Score ≥4.
- Participants who had participated in clinical studies of other drugs or medical devices before enrollment and did not meet the primary study endpoint time limit.
- The investigator judged that the patient had poor compliance and could not complete the study as required.
- The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy.
- Patient was allergic to the contrast agent.
- Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study.
- Patients have clotting disorders or are on anticoagulant therapy.
- Patients have a history of opioid addiction.
- Researchers believe that patients who are not suitable to participate in this trial.
Exclusion
Key Trial Info
Start Date :
June 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06029153
Start Date
June 15 2023
End Date
November 30 2024
Last Update
December 31 2024
Active Locations (1)
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1
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550001