NCT06735833NARecruiting
MMA Embolization for Refractory Chronic Migraine
Cerenovus, Part of DePuy Synthes Products, Inc.
Start Date
4/23/2025
Completion Date
7/31/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to 65 years
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 primary headache types, or secondary headache types except medication overuse headache
2. Patients with diagnosis of hemiplegic migraine or migrainous infarct
3. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc
4. Women who are pregnant, lactating, or who are of childbearing age
5. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Participants in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required
Interventions
DEVICE
Middle Meningeal Artery embolization
Conditions
Migraine Disorders
Locations
Barrow Neurological Institute at St. Joseph's Hospital
Phoenix, Arizona 85013
United States
John Muir Physician Network Clin. Research Center
Walnut Creek, California 94598
United States
Hartford Hospital
Hartford, Connecticut 06032
United States
University of Buffalo Medical Center
Buffalo, New York 14203
United States
Mount Sinai
New York, New York 10029
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Semmes Murphey Foundation
Memphis, Tennessee 38120
United States
West Virginia University
Morgantown, West Virginia 26506
United States