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

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ClinicalTrials.gov Identifier: NCT02734576
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 our 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.

Condition or disease Intervention/treatment Phase
Tinnitus Pulsatile Tinnitus Venous Sinus Stenosis Dural Sinus Stenosis Device: Venous Sinus Stenting Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis
Study Start Date : May 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Venous Sinus Stenting
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


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline Grade on the Tinnitus Handicap Inventory Questionnaire [ Time Frame: 24 months ]
  2. Procedure related and device related complications [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe or catastrophic venous pulsatile tinnitus defined as Grades 4 or 5 on Tinnitus Handicap Inventory
  • 50% 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734576


Contacts
Contact: Athos Patsalides, MD MPH 2127462821 atp9002@med.cornell.edu
Contact: Jennifer Yoo 2127462821

Locations
United States, New York
New York Presbyterian Hospital/ Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Athos Patsalides, MD MPH    212-746-2821    atp9002@med.cornell.edu   
Contact: Jennifer Yoo    2127462821      
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Athos Patsalides, MD MPH Weill Medical College of Cornell University
Study Director: Srikanth Boddu, MD Weill Medical College of Cornell University
More Information

Responsible Party: Athos Patsalides MD, Associate Professor of Radiology in Neurological Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02734576     History of Changes
Other Study ID Numbers: AP-003
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Athos Patsalides MD, Weill Medical College of Cornell University:
Venous Sinus Stenting
Dural Sinus Stenting

Additional relevant MeSH terms:
Constriction, Pathologic
Tinnitus
Pathological Conditions, Anatomical
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms