Actively Recruiting
Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus Endovascular Treatment by Venous Stenting An Efficacy Study
Led by University Hospital, Bordeaux · Updated on 2025-02-11
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
F
French Ministry of Social Affairs and Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of venous stenting for treating dural arteriovenous fistulae (DAVF) that cause pulsatile tinnitus (PT). This trial compares venous stenting to no treatment in patients with low-grade DAVF, focusing on changes in Cognard's Classification at six months. The study aims to find a simpler, lower-risk option than existing treatments for patients with PT due to DAVF without neurological risk. Participants in the experimental group will receive venous stenting via a venous approach such as femoral, brachial, or jugular puncture. The stent is placed at the fistulous sinus, sometimes using multiple stents and balloon angioplasty. Antiaggregation medication with aspirin and clopidogrel or ticagrelor is given around the procedure. The control group will receive standard care with no treatment during the first six months, after which treatment may proceed as usual. Participants will be assessed at baseline and at 6, 12, and 24 months, including angiographic evaluation of DAVF, clinical scales like the THI score, modified Rankin Scale, and monitoring of symptoms such as concentration troubles, sleep problems, headaches, and dizziness. Safety is monitored through rates of stent thrombosis and deployment success. The total follow-up period extends up to 24 months to observe long-term outcomes.
CONDITIONS
Brief Title
Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient experiencing disabling pulsatile tinnitus
- Pulsatile tinnitus anatomically linked to a dural arteriovenous fistula (DAVF)
- DAVF classified as Type I or IIa by Cognard's classification via digital subtraction angiography
- DAVF located on the sigmoid, lateral, or posterior longitudinal sinus
- Fistula length suitable for use of up to two stents
- Women of childbearing potential must use highly effective contraception during study procedures
- Affiliated with or beneficiary of health insurance
- Signed informed consent provided
You will not qualify if you...
- DAVF not eligible for endovascular treatment
- DAVF classified as IIb or higher according to Cognard's classification
- Severe sinus stenosis or occlusion preventing sinus stenting
- Recent thrombophlebitis at fistulous dural sinus site within last 3 months
- Previous surgery or radiotherapy for DAVF
- Multiple DAVF present
- Contralateral sinus aplasia or occlusion
- Contraindication to liquid embolic agent use
- Participation in another medical device clinical study
- Conditions preventing attendance at 6-month follow-up
- Known allergy to heparin, aspirin, Coumadin, Warfarin, or other antiplatelet drugs
- Surgery including endovascular procedures within 30 days prior
- Intracranial or subarachnoid hemorrhage within 30 days prior
- Sensitivity to radiographic contrast agents
- Sensitivity to nickel, titanium, or their alloys
- Renal failure with serum creatinine above 2.5 mg/dl or GFR below 30
- Contraindication to MRI or angiography
- Pregnant, lactating, or planning pregnancy during study
- Unable or unwilling to provide informed consent
- Under legal protection or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants assigned to venous stenting undergo the stenting procedure involving the placement of one or two stents in the fistulous sinus, accompanied by an antiaggregation protocol.
1 visit (in-person)
Duration - Up to 24 months
Participants in the no treatment group are observed without active intervention to assess the natural progression of their condition.
Visits at baseline, Month 6, Month 12, and Month 24
Duration - Up to 24 months
All participants are followed up to evaluate treatment efficacy, safety, and symptom changes including pulsatile tinnitus and neurological assessments.
Visits at Month 6, Month 12, and Month 24
Trial Site Locations
Total: 1 location
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
Research Team
X
Xavier BARREAU, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here