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

NCT02734576 | Terminated Results DMC FDA Device

• 1 other identifier: 1508016520
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus; Pulsatile Tinnitus; Venous Sinus Stenosis; Dural Sinus Stenosis

Keywords

Venous Sinus Stenting; Dural Sinus Stenting

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Complete or Near-complete Resolution of Tinnitus

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

  12 months

• Change in Number of Patients With Improvement of More Than One Grade in the Tinnitus Handicap Inventory Questionnaire

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

  1, 6, 12, and 24 months after stent placement.

Secondary Outcomes (4)

• Number of Subjects With Clinical Recurrence of Their Tinnitus

  24 months

• Number of Subjects With Long-term Patency of the Stent

  12 months

• Number of Adverse Events Probably or Possibly Related to the Treatment

  24 months

• Number of Severe Adverse Events Probably or Possibly Related to the Treatment

  24 months

Study Arms (1)

Venous Sinus Stenting

EXPERIMENTAL

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

Device: Venous Sinus Stenting with the Precise Pro Stent

Interventions

Venous Sinus Stenting with the Precise Pro Stent DEVICE

Enrolled patients will undergo a minimally invasive procedure that involves placement of a stent in the cerebral venous sinuses (large veins of the brain).

Venous Sinus Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe or catastrophic venous pulsatile tinnitus defined as Grades 4 or 5 on Tinnitus Handicap Inventory
• % or more stenosis of the lateral venous sinus on Magnetic Resonance Venogram (MRV) or Computed Tomographic Venogram (CTV\_, ipsilateral to the side of more severe tinnitus
• Failure of conservative or non-surgical therapies (including sound therapy, sound masking, hearing aids, tinnitus retraining (desensitization) therapy. Failure is defined as Grades 4 or 5 on the Tinnitus Handicap Inventory despite prior treatments that have lasted for at least 3 months.

You may not qualify if:

• Non-pulsatile tinnitus
• Contra-indication to iodinated contrast
• Contra-indication to antiplatelet therapy
• Contra-indication to general anesthesia
• Pregnancy or plans for immediate pregnancy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Presbyterian Hospital/ Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Athos Patsalides
• Organization: North Shore University Hospital Northwell Health

apatsalides@northwell.edu

516-562-2244

Study Officials

• Athos Patsalides, MD MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 12, 2016
• Study Start: January 24, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 2, 2021
• Results First Posted: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)