Trial Outcomes & Findings for Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis (NCT NCT02734576)

NCT ID: NCT02734576

Last Updated: 2021-04-02

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-04-02

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Venous Sinus Stenting n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Sex: Female, Male Female	9 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Venous Sinus Stenting n=10 Participants 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.
Number of Patients With Complete or Near-complete Resolution of Tinnitus	10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Venous Sinus Stenting n=10 Participants 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.
Change in Number of Patients With Improvement of More Than One Grade in the Tinnitus Handicap Inventory Questionnaire	10 Participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	Venous Sinus Stenting n=10 Participants 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.
Number of Subjects With Clinical Recurrence of Their Tinnitus	0 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Venous Sinus Stenting n=10 Participants 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.
Number of Subjects With Long-term Patency of the Stent	10 Participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	Venous Sinus Stenting n=10 Participants 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.
Number of Adverse Events Probably or Possibly Related to the Treatment	0 adverse events

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	Venous Sinus Stenting n=10 Participants 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.
Number of Severe Adverse Events Probably or Possibly Related to the Treatment	0 severe adverse events

Adverse Events

Venous Sinus Stenting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Athos Patsalides

North Shore University Hospital Northwell Health

Phone: 516-562-2244

Email: apatsalides@northwell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place