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 — PROCEDURE
    Catheter 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 vein
    Subjects 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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic FloridaJacksonvilleFlorida32224-

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