MedTrace Logo

Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

NCT01407809 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-08-03

No results posted yet for this study

Summary

Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Some cases of IIH are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with IIH after the narrow veins of the brain were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe IIH refractory to medical management.

Conditions

  • Idiopathic Intracranial Hypertension (IIH)

Interventions

DEVICE

Venous Sinus Stenting

Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Athos Patsalides, MD, MPH · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2020-06-01
Completion
2020-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01407809 on ClinicalTrials.gov