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Operative Procedures Vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial

NCT02513914 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-26

No results posted yet for this study

Summary

Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is characterized by elevated intracranial pressure, headache, and if severe, vision loss. IIH is difficult to treat. Medical management may not adequately resolve the symptoms, and surgical management (primarily through cerebrospinal fluid \[CSF\] shunting) has a high failure rate. Recently, a relationship between IIH and stenosis of the dural venous sinuses (the veins that drain blood from the brain) has been reported. In patients with IIH in whom there is stenosis of one or more dural venous sinuses, placing a stent in the venous sinus may improve patients' objective symptoms (such as visual loss and papilledema) and subjective symptoms (such as headache). This study will determine whether dural venous sinus stenting is as effective as CSF shunting (considered the standard surgical treatment) in treating IIH patients who have moderate vision loss and stenosis of the dural venous sinuses.

Conditions

  • Pseudotumor Cerebri
  • Idiopathic Intracranial Hypertension (IIH)

Interventions

DEVICE

Dural Venous Sinus Stenting

See Dural Venous Sinus Stenting arm.

DEVICE

Cerebrospinal Fluid Shunting

See Cerebrospinal Fluid Shunting arm.

Sponsors & Collaborators

  • Barrow Neurological Institute

    collaborator OTHER

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Felipe C Albuquerque, MD · Barrow Neurosurgical Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513914 on ClinicalTrials.gov