Recruiting

Lumbar Vein Embolization

Sponsor:

Mayo Clinic

Code:

NCT06077747

Conditions

Chronic Headache

Nutcracker Phenomenon, Renal

Nutcracker Syndrome, Renal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coil Embolization of the Lumbar Vein

Study Details

Brief summary:

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.

Conditions

Chronic Headache

Nutcracker Phenomenon, Renal

Nutcracker Syndrome, Renal

Study ID

NCT06077747

Start date

Sep 17, 2024

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • Change in Migraine Disability Assessment [ Time Frame: 1,3,7,14, and 28 days after the procedure and then monthly for 17 months ]

Central Contacts and Locations

Central contacts

Julia Santos

904-953-3280Santos.Julia@mayo.edu

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-18.