Dural Venous Sinus Stenting for Pseudotumor Cerebri

Phase-Based Progress Estimates
University of Washington Department of Neurosurgery, Seattle, WAPseudotumor Cerebri+1 MoreDural Venous Sinus Stenting - Device
All Sexes
What conditions do you have?

Study Summary

This trial will compare dural venous sinus stenting to the current standard treatment (CSF shunting) for pseudotumor cerebri (IIH) patients with moderate vision loss and stenosis of the dural venous sinuses.

Eligible Conditions
  • Pseudotumor Cerebri
  • Idiopathic Intracranial Hypertension

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Study entry, six months and One year

Six months
Perimetric mean deviation (PMD) at six months
Resolution of venous stenosis pressure gradient at six months
Six months and One year
Total number of IIH-related surgeries at one year
Study entry, six months and One year
Quality of life
Study entry, two-weeks post-operative and six months
Visual acuity
Two-weeks post-operative, six months and One year
Pharmaceutical Preparations

Trial Safety

Trial Design

2 Treatment Groups

Cerebrospinal Fluid Shunting
1 of 2
Dural Venous Sinus Stenting
1 of 2

Active Control

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Dural Venous Sinus Stenting · No Placebo Group · N/A

Dural Venous Sinus Stenting
Experimental Group · 1 Intervention: Dural Venous Sinus Stenting · Intervention Types: Device
Cerebrospinal Fluid Shunting
ActiveComparator Group · 1 Intervention: Cerebrospinal Fluid Shunting · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study entry, six months and one year

Who is running the clinical trial?

Barrow Neurological InstituteOTHER
20 Previous Clinical Trials
5,791 Total Patients Enrolled
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
58 Previous Clinical Trials
14,074 Total Patients Enrolled
Felipe C Albuquerque, MDPrincipal InvestigatorBarrow Neurosurgical Associates

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

Are volunteers able to participate in this experiment right now?

"Indeed, the records on clinicaltrials.gov support that this medical trial is actively accepting participants. It was initially posted in June 3rd 2020 and last revised on September 20th 2021; it needs 80 individuals to be recruited from 2 different medical centres." - Anonymous Online Contributor

Unverified Answer

What is the capacity for participants in this investigation?

"Indeed, the information found on clinicaltrials.gov reveals that recruitment for this study is ongoing. It was first posted on June 3rd 2020 and has undergone its latest update as of September 20th 2021. The trial requires 80 participants to be recruited from 2 medical sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.