NCT02734576

Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis

Terminated NA Results posted Last updated 2 April 2021

What this trial tests

NA trial testing Venous Sinus Stenting with the Precise Pro Stent in Tinnitus in 10 participants. Terminated before completion.

Timeline

24 January 2017

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	24 January 2017
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Venous Sinus Stenting with the Precise Pro Stent

Conditions studied

• Tinnitus — all drugs for Tinnitus →
• Pulsatile Tinnitus — all drugs for Pulsatile Tinnitus →
• Venous Sinus Stenosis — all drugs for Venous Sinus Stenosis →
• Dural Sinus Stenosis — all drugs for Dural Sinus Stenosis →

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, any sex, with Tinnitus or Pulsatile Tinnitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Complete or Near-complete Resolution of Tinnitus Primary · 12 months

Tinnitus will be measured by: No, slight, mild, or moderate (Grades 1, 2, and 3) on Tinnitus Handicap Inventory.

Group	Value	95% CI
Venous Sinus Stenting	10

Change in Number of Patients With Improvement of More Than One Grade in the Tinnitus Handicap Inventory Questionnaire Primary · 1, 6, 12, and 24 months after stent placement.

Tinnitus will be measured by: No, slight, mild, or moderate (Grades 1, 2, and 3) on Tinnitus Handicap Inventory.

Group	Value	95% CI
Venous Sinus Stenting	10

Number of Subjects With Clinical Recurrence of Their Tinnitus Secondary · 24 months

Clinical recurrence is if "No" tinnitus has changed back to "Slight, Mild or "Moderate."

Group	Value	95% CI
Venous Sinus Stenting	0

Number of Subjects With Long-term Patency of the Stent Secondary · 12 months

A subject is considered to have long-term patency if there is 100% patency of the stent at 12 months.

Group	Value	95% CI
Venous Sinus Stenting	10

Number of Adverse Events Probably or Possibly Related to the Treatment Secondary · 24 months

Group	Value	95% CI
Venous Sinus Stenting	0

Number of Severe Adverse Events Probably or Possibly Related to the Treatment Secondary · 24 months

Group	Value	95% CI
Venous Sinus Stenting	0

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Resolution of Pulsatile Tinnitus after Venous Sinus Stenting in Patients with Idiopathic Intracranial Hypertension.
   Boddu S, Dinkin M, Suurna M, Hannsgen K, et al · · 2016 · cited 50× · PMID 27768690 · DOI 10.1371/journal.pone.0164466
2. Venous sinus stenting for intractable pulsatile tinnitus: A review of indications and outcomes.
   Fiani B, Kondilis A, Doan T, Runnels J, et al · · 2021 · cited 11× · PMID 33767885 · DOI 10.25259/sni_1_2021