NCT05922514

A Clinical Registry of Spontaneous Intracranial Hypotension

Spontaneous Intracranial Hypotension Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to determine the efficacy of paraspinal vein embolization for treatment of digital subtraction myelography (DSM) or CT myelography (CTM) confirmed cerebrospinal fluid (CSF)-venous fistulas so that researchers can inform the development and design of future clinical trials of this technique.

Conditions

• Spontaneous Intracranial Hypotension

Interventions

Type	Name	Description
PROCEDURE	Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula	Transvenous embolization of a cerebrospinal fluid-venous fistula performed via percutaneous venous access under fluoroscopic guidance. The procedure involves catheterization of the paraspinal or epidural venous system draining the fistula and delivery of an embolic agent to occlude the pathological venous outflow and eliminate CSF egress. The goal is to achieve durable fistula occlusion and resolution of spontaneous intracranial hypotension symptoms.

Timeline

• Start date: 2023-06-18
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-06-28
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States