Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology

NCT06077747 | Recruiting

• 1 other identifier: 23-004668
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in headache pain

  Measured by a visual analogue scale (VAS) where 0 = no pain, 5= moderate pain, 10= worst pain

  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

  1,3,7,14, and 28 days after the procedure and then monthly for 17 months

Secondary Outcomes (2)

• Adverse Events

  1,3,7,14, and 28 days after the procedure and then monthly for 17 months

• Serious Adverse Events

  1,3,7,14, and 28 days after the procedure and then monthly for 17 months

Study Arms (1)

Coil embolization of lumbar vein

EXPERIMENTAL

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

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.

Coil embolization of lumbar vein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Headache Disorders; Renal Nutcracker Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Zlatko Devcic, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Santos

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: September 17, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)