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Stent

Venous Sinus Stenting for Tinnitus

N/A
Waitlist Available
Led By Athos Patsalides, MD MPH
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 6, 12, and 24 months after stent placement.
Awards & highlights

Summary

There have been few published studies that examine the efficacy and safety of endovascular treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show that venous sinus stenting could represent a viable alternative for refractory pulsatile tinnitus patients with venous sinus stenosis. The purpose of this study is to evaluate the safety and efficacy of this procedure in a controlled fashion, using strict inclusion and exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to provide robust data regarding the safety and efficacy of venous sinus stenting for patients with pulsatile tinnitus.

Eligible Conditions
  • Tinnitus
  • Venous Sinus Stenosis
  • Dural Sinus Stenosis
  • Pulsatile Tinnitus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6, 12, and 24 months after stent placement.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6, 12, and 24 months after stent placement. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Number of Patients With Improvement of More Than One Grade in the Tinnitus Handicap Inventory Questionnaire
Number of Patients With Complete or Near-complete Resolution of Tinnitus
Secondary outcome measures
Number of Adverse Events Probably or Possibly Related to the Treatment
Number of Severe Adverse Events Probably or Possibly Related to the Treatment
Number of Subjects With Clinical Recurrence of Their Tinnitus
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venous Sinus StentingExperimental Treatment1 Intervention
Venous sinus stenting is the experimental procedure being tested in this protocol and consists of placing a stent into the narrowed veins of the brain. Under general anesthesia, a catheter will be inserted through a vein the upper part of the leg (groin area) and guided through the veins all the way to neck and the head. Then, a balloon will be advanced through the catheter and positioned across the stenosis. The balloon will be carefully inflated for a few seconds. This process is called angioplasty and will partially re-open the narrowing, making placement of the stent easier. The balloon will be removed and then the stent will be advanced through the catheter in neck across the stenosis and carefully deployed. After the procedure, the participants will stay in the intensive care unit for 24 hours for observation

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,319,176 Total Patients Enrolled
Athos Patsalides, MD MPHPrincipal InvestigatorWeill Medical College of Cornell University
~1 spots leftby Aug 2025