An interventional study of Coil Embolization of the Lumbar Vein in Chronic Headache, Nutcracker Phenomenon, Renal and Nutcracker Syndrome, Renal, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
This is a feasibility, non-randomized, non-blinded clinical trial enrolling patients who are at least 18 years of age for the treatment of chronic headache in the setting of Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus enhancement.
Patients are initially evaluated by a fellowship trained headache neurologist to obtain a detailed headache history, VAS score, MIDAS score, and physical examination. They are also evaluated by a neuro ophthalmologist with fundoscopic examination to assess for disc edema. A lab work-up is performed including complete blood count, basic metabolic panel, and microscopic urinalysis. A lumbar puncture and imaging work-up are then obtained as well.
Patients will proceed to an MRI to evaluate for Nutcracker physiology, retrograde lumbar vein flow, and epidural venous plexus enhancement if they meet the following criteria:
MRI, MRA head and neck and MR venogram negative for possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc
a. Transverse sinus stenosis is allowed to proceed
Exposed to CSF pressure/volume lowering medications
a. Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response
If they are interested in the clinical trial, they will be evaluated in clinic by a fellowship trained interventional radiologist to review the following:
For patients that are still eligible and interested they will proceed with venography. Venography involves an evaluation of the left renal vein and left lumbar vein to confirm the findings on the MRI. If catheter-based venography confirms Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus enhancement they will then enter the clinical trial. Embolization of the lumbar vein will be performed. A follow-up venogram will then be performed to ensure there is no further retrograde lumbar vein flow.
After the embolization patient's will be followed for symptom evaluation at 1,3,7,14, and 28 days after the procedure and then monthly. They will also have a follow-up physical examination at 1 month, 3 months, 6 months and then every 6 months post-procedure. They will be followed for a total of 18 months. Some patients may need follow-up laboratory work-up and MRI post-procedure as standard of care.
145 studies on the registry are indexed under Headache Disorders; 37 are open to participants now.
This study's planned enrollment of 4 is below the median of 60 across 98 interventional studies indexed under Headache Disorders.
Browse Headache Disorders studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Coil Embolization of the Lumbar Vein
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.
Change in headache pain
Measured by a visual analogue scale (VAS) where 0 = no pain, 5= moderate pain, 10= worst pain
Time frame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Change in Migraine Disability Assessment
Measured by the Migraine Disability Assessment Test
Time frame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Adverse Events
Number of adverse events defined as any unwanted symptom that occurred from embolizing the lumbar vein such as flank pain, proteinuria, hematuria, or pelvic congestion.
Time frame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Serious Adverse Events
Number of serious adverse events defined as any serious unexpected complication during or after the embolization that would result in death, is life threatening, requires prolonged hospitalization, causes persistent or significant disability or incapacity, or another condition that represents significant hazards.
Time frame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Sep 2027, 36 months after the start.
Of 41 non-industry interventional studies with no phase under Headache Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 42. This study's planned 36 months is above that.
Counting every sponsor, half of 43 studies reached it within 20 months; a quarter within 7 and three quarters within 42.
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