What this study is
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.
What's being tested
- Coil Embolization of the Lumbar Vein
Intervention · 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
- Official title
- Lumbar Vein Embolization for the Treatment of Chronic Headache in Patients With Nutcracker Physiology and Retrograde Lumbar Vein Flow With Epidural Venous Plexus Enhancement
- Sponsor
- Mayo Clinic
- Conditions
- Chronic Headache · Nutcracker Phenomenon, Renal · Nutcracker Syndrome, Renal
- Enrolling
- 4 people
- Starts
- 2024-09-17
- Est. completion
- 2027-09
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Daily headache from onset lasting > 3 months.
- Headache described as pressure sensation.
- Headache worsened in the Trendelenburg position.
- Exposed to CSF pressure/volume lowering medications.
- Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response.
- Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications.
- MRI demonstrates that Nutcracker physiology is present.
- Decreased SMA angle, renal vein narrowing, decreased AMD.
- Retrograde lumbar vein flow and early EVP enhancement.
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Negative pregnancy test.
You can't join if
- Evidence of disc edema.
- Positive urinalysis for hematuria or proteinuria.
- Abnormal CBC or CMP.
- MRI, MRA head and neck and MR venogram with a possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic Florida
Jacksonville, Florida, United States
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 23-004668
Principal investigator
Zlatko Devcic, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.