Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment

NCT05679271 | Recruiting DMC

• 1 other identifier: CHUBX 2022/20
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized trial to assess the angiographic efficacy of venous stenting in dural arteriovenous fistulae (DAVF) via improvment on Cognard's Classification as compared to no intervention at 6 months Participants belonging to experimental group will be treated using venous stenting. DAVF will be assessed by angiography at 6 months follow-up. Participants belonging to control group will be followed accordingly to standard of care (no treatment). After 6 months, control group patients can be treated by any means accordinlgly to standard of care.

Conditions

Pulsatile Tinnitus

Keywords

Dural arteriovenous fistulae; Pulsatile tinnitus; Venous Stenting

Outcome Measures

Primary Outcomes (1)

• Cognard's classification grade

  Cognard's classification status : from type I (Anterograde drainage into venous sinus) to Type V (Drainage into the spinal perimedullary veins)

  Month 6

Secondary Outcomes (8)

• THI score

  Baseline, Month 6, Month 12, Month 24

• modified Rankin Scale

  Baseline, Month 6

• Rate of stent thrombosis

  Month 6, Month 12, Month 24

• unsuccessful stent deployment

  Baseline

• Concentration troubles

  Baseline, Month 6, Month 12, Month 24

Study Arms (2)

venous stenting

EXPERIMENTAL

Venous stenting associated to antiaggregation protocol: Venous stenting: venous approach can be performed via femoral, brachial or jugular puncture. Autoexpansible stent should delivered at the level of the fistulous sinus. If distal access catheter is wide enough, stent can be delivered directly through it. After partial deployment of the stent, Labbe vein's flow may be restricted. If necessary, several stents can be used in the same procedure to cover the whole length of fistulous sinus area. After stent deployment, ballon angioplasty is compulsory and must be performed using a ballon of equivalent size to the stent. The procedure ends after stent deployment and angiographic arterial post-op controls. Antiaggregation protocol: aspirin (160mg for 3 months) + clopidogrel (75mg/d 5 days before stenting and 75mg/d for 1 month after stenting) OR ticagrelor (180mg 2h before stenting and 90mg twice a day for 1 month) in case of clopidogrel platelet resistance.

Device: Venous stenting

no treatment

ACTIVE COMPARATOR

standard care (no treatment)

Other: Standard of care

Interventions

Venous stenting DEVICE

venous stenting associated to antiaggregation protocol

venous stenting

Standard of care OTHER

observation: no treatment

no treatment

Eligibility Criteria

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

You may qualify if:

• Patient presenting invalidating pulsatile tinnitus
• Patient presenting with PT anatomically correlated with a DAVF
• Type I or IIa DAVF on digital subtraction angiography (DSA), according to Cognard's classification.
• DAVF located on sigmoid , lateral or posterior longitudinal sinus.
• Fistula length compatible with use of up to two stents
• Highly effective contraception for women of childbearing potential, maintained during research procedures
• Affiliated or beneficiary of health insurance
• Signed informed consent

You may not qualify if:

• Patient with DAVF not eligible for endovascular treatment .
• DAVF classification of IIb or more according to Cognard's classification.
• DAVF with severe sinus stenosis or occlusion judged as nor eligible for sinus stenting.
• DAVF showing evidence of recent (inferior to 3 months) thrombophlebitis at the site of fistulous dural sinus.
• Patient with DAVF previously treated with surgery or radiotherapy.
• Patient with multiple DAVF
• Controlateral sinus aplasia or occlusion
• Patient presenting contra-indication to the use of LEA according to the instructions For Use.
• Patient participating in another clinical study evaluating another medical device,
• Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up as recommended by the study protocol at 6 months.
• Patient with any known allergy to heparin, acetylsalicylic acid, Coumadin , Warfarin or other antiplatelet medications
• Patient has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
• Patient has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure
• Known serious sensitivity to radiographic contrast agents.
• Known sensitivity to nickel, titanium metals, or their alloys

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• French Ministry of Social Affairs and Health: collaborator

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Xavier BARREAU, MD

CONTACT

+33 556 79 56 04; xavier.barreau@chu-bordeaux.fr

Study Design

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

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 10, 2023
• Study Start: August 22, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)