RECRUITINGINTERVENTIONAL
MMA Embolization for Refractory Chronic Migraine
Feasibility Study to Evaluate the Initial Safety and Effectiveness of TRUFILL n-BCA Liquid Embolic System in Middle Meningeal Artery Embolization for the Preventive Treatment of Refractory Chronic Migraine
About This Trial
This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine.
Who May Be Eligible (Plain English)
Participant Inclusion Criteria, Candidates for this study must meet ALL the following Who May Qualify:
1. Patient is between 18 and 65 years of age (inclusive) at the time of consent.
2. Age of onset of Chronic Migraine ≤ 64 years.
3. Age of onset of migraine diagnosis \< 50 years.
4. Patient has a current diagnosis of refractory migraine.
5. Patient has a current diagnosis of Chronic migraine.
Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:
1\. Patients with a history for the last 2 years of other types of headache. 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.
6\. Women who are pregnant, lactating, or who are of childbearing age. 7. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:
1. Patient is between 18 and 65 years of age (inclusive) at the time of consent.
2. Age of onset of Chronic Migraine ≤ 64 years.
3. Age of onset of migraine diagnosis \< 50 years.
4. Patient has a current diagnosis of refractory migraine.
5. Patient has a current diagnosis of Chronic migraine.
Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:
1\. Patients with a history for the last 2 years of other types of headache. 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.
6\. Women who are pregnant, lactating, or who are of childbearing age. 7. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required.
Treatments Being Tested
DEVICE
Middle Meningeal Artery embolization
Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
Locations (7)
Hartford Hospital
Hartford, Connecticut, United States
University of Buffalo Medical Center
Buffalo, New York, United States
Mount Sinai
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Semmes Murphey Foundation
Memphis, Tennessee, United States
West Virginia University
Morgantown, West Virginia, United States