Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Bordeaux
RECRUITING
Bordeaux
Contact Information
Primary
Xavier BARREAU, MD
xavier.barreau@chu-bordeaux.fr
+33 556 79 56 04
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2027-12
Participants
Target number of participants: 48
Treatments
Experimental: venous stenting
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.
Active_comparator: no treatment
standard care (no treatment)
Sponsors
Collaborators: French Ministry of Social Affairs and Health
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov