RecruitingNot ApplicableNCT06735833

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


Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Enrollment

70 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • Patient is between 18 and 65 years of age (inclusive) at the time of consent.
  • Age of onset of Chronic Migraine ≤ 64 years.
  • Age of onset of migraine diagnosis \< 50 years.
  • Patient has a current diagnosis of refractory migraine.
  • Patient has a current diagnosis of Chronic migraine.

Exclusion Criteria2

  • \. 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.
  • \. 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.

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Interventions

DEVICEMiddle 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

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NCT06735833


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