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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This study is to test the safety and feasibility of a procedure called embolization of the middle meningeal arteries (MMA), using a product called Onyx. Embolization creates a plug in the arteries. MMA embolization with Onyx is not approved for use in patients with migraines, but is currently used in patients with subdural hematomas. The FDA is allowing the use of Onyx in this study. It is thought that by using Onyx to block the middle meningeal arteries, the amount of migraine-causing substances which are released into the brain's bloodstream will be reduced. The company that manufactures Onyx, Medtronic, is providing the supplies for this study.
Participants will be in the study for about 8 months after enrolling, including 6 months of follow up after the procedure. The participants will be asked to complete a daily headache diary and continue the participant's regular migraine medications. Participants will also have several clinic visits and be asked to provide blood samples for research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants will undergo embolization of the middle meningeal arteries with Onyx. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embolization of middle meningeal arteries | Device | Participants will undergo embolization of the middle meningeal arteries with Onyx |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of specified adverse events related to the study | Strokes (ischemic and hemorrhagic), blindness, facial palsy, epidural hematoma, and death within 30 days of the embolization | 30 days after procedure |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Szajna | Contact | 000-000-0000 | ksajna1@jhmi.edu | |
| Kallan Dirmeyer | Contact | 000-000-0000 | kdirmey1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Risheng Xu, MD, PhD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine | Recruiting | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |