Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Mayo Clinic
- Study ID
- NCT06077747
- Status
- Recruiting
Conditions
- Chronic Headache
- Nutcracker Phenomenon, Renal
- Nutcracker Syndrome, Renal
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Coil Embolization of the Lumbar Vein — PROCEDURECatheter based venography will first confirm Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus congestion. The lumbar vein will then be coil embolized.
Study Details
The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic headaches in patients with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion. All patients are extensively evaluated by a headache trained Neurologist confirming high pressure headache refractory to other treatments.
Key Dates
- Start date
- Sep 17, 2024
- Status verified
- Nov 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 4 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Coil embolization of lumbar veinSubjects with confirmed Nutcracker physiology, retrograde lumbar vein flow, and epidural venous plexus congestion with a high pressure headache will have coil embolization of the lumbar vein.
Primary Outcome Measure
Change in headache pain [ Time Frame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months ]
Central Contacts
- Julia Santos904-953-3280
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | - |
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