Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology

NCT ID: NCT06077747

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2027-09-30

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.

Detailed Description

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:

1. Daily headache from onset lasting > 3 months

2. Headache described as pressure sensation

3. Headache worsened in the Trendelenburg position

4. 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

5. 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

6. Failed at least 3 typical headache preventative medications from different classes: antidepressants, antiepileptic, and blood pressure If these criteria are met, they will undergo an MRI to evaluate for Nutcracker physiology, retrograde lumbar vein flow, and epidural venous plexus enhancement. For those patients that demonstrate Nutcracker physiology with retrograde lumbar vein flow and EVP enhancement they would be eligible for the clinical trial.

If they are interested in the clinical trial, they will be evaluated in clinic by a fellowship trained interventional radiologist to review the following:

1. Procedural sedation: moderate sedation versus general anesthesia

2. Prior contrast allergies

3. Consent for procedure

4. Prior to venography the patient is taken off all headache medications for 4 weeks.

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.

Conditions

Chronic Headache; Nutcracker Phenomenon, Renal; Nutcracker Syndrome, Renal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Coil Embolization of the Lumbar Vein

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Zlatko Devcic

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zlatko Devcic, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julia Santos

Role: CONTACT

Santos.Julia@mayo.edu

904-953-3280

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

23-004668

Identifier Type: -

Identifier Source: org_study_id