Actively Recruiting
Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
Led by University Hospital, Bordeaux · Updated on 2025-02-11
48
Participants Needed
1
Research Sites
170 weeks
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
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
Official 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 presenting invalidating pulsatile tinnitus
- Pulsatile tinnitus anatomically linked to a dural arteriovenous fistula (DAVF)
- Type I or IIa DAVF confirmed by digital subtraction angiography (DSA) using Cognard's classification
- DAVF located on the sigmoid, lateral, or posterior longitudinal sinus
- Fistula length suitable for use of up to two stents
- Women of childbearing potential using highly effective contraception during the study
- Affiliated or beneficiary of health insurance
- Signed informed consent
You will not qualify if you...
- DAVF not eligible for endovascular treatment
- DAVF classified IIb or higher by Cognard's classification
- Severe sinus stenosis or occlusion making sinus stenting unsuitable
- Recent (under 3 months) thrombophlebitis at fistula site
- Previous DAVF treatment with surgery or radiotherapy
- Multiple DAVF present
- Contralateral sinus aplasia or occlusion
- Contraindication to liquid embolic agents
- Participation in another medical device clinical study
- Any condition preventing follow-up visits at 6 months
- Known allergy to heparin, aspirin, Coumadin, Warfarin, or antiplatelet drugs
- Surgery or endovascular procedure within 30 days before study
- Intracranial or subarachnoid hemorrhage within 30 days before study
- Serious sensitivity to radiographic contrast agents
- Known allergy to nickel, titanium, or their alloys
- Renal failure defined by serum creatinine > 2.5 mg/dl or GFR < 30
- Contraindications to MRI or angiography
- Women who are pregnant, lactating, or planning pregnancy during the study
- Unable or unwilling to understand or consent to the study
- Under legal protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
Research Team
X
Xavier BARREAU, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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