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
Cerenovus, Part of DePuy Synthes Products, Inc.
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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. Patien…
Interventions
- DeviceMiddle Meningeal Artery embolization
Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
Locations (9)
- Barrow Neurological Institute at St. Joseph's HospitalPhoenix, Arizona
- John Muir Physician Network Clin. Research CenterWalnut Creek, California
- Hartford HospitalHartford, Connecticut
- University of Buffalo Medical CenterBuffalo, New York
- Mount SinaiNew York, New York
- Stony Brook University Medical CenterStony Brook, New York