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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05679271

Collaborator

French Ministry of Social Affairs and Health (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulsatile Tinnitus	Device: Venous stenting Other: Standard of care	N/A

Detailed Description

DAVF are frequently revealed as a cause of invalidating pulsatile tinnitus (PT). Endovascular treatment (EVT) of DAVF using liquid embolic agent (LEA) is currently performed when an hemorrhagic risk of intracranial hemorrhage is identified (high grade DAVF). PT alone may not be a sufficient condition to offer EVT because procedure-related risks may overcome clinical benefits specifically in case of extended shunts requiring complex procedures. Stenting of dural sinus may represent an alternative to LEA-EVT with a simple and low risk procedure. Thus PT could be cured even in case of low grade DAVF without neurologic risk.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Venous stenting venous stenting associated to antiaggregation protocol
Active Comparator: no treatment standard care (no treatment)	Other: Standard of care observation: no treatment

Arm

Intervention/Treatment

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.

Device: Venous stenting

venous stenting associated to antiaggregation protocol

Active Comparator: no treatment

standard care (no treatment)

Other: Standard of care

observation: no treatment

Outcome Measures

Primary Outcome Measures

Cognard's classification grade [Month 6]
Cognard's classification status : from type I (Anterograde drainage into venous sinus) to Type V (Drainage into the spinal perimedullary veins)

Secondary Outcome Measures

THI score [Baseline, Month 6]
THI (Tinnitus Handicap Inventory) score (based on 100 points scale from Grade 1 (<16 points) Slight or no handicap to Grade 5 (>=78 points) Catastrophic handicap)
Composite criteria with angiographic OR clinical modification [Month 6]
Composite criteria with angiographic (Cognard's classification) OR clinical modification (13 points improvment on THI scoring or THI score equal to 0)
modified Rankin Scale [Baseline, Month 6]
mRS Neurological score (from 0 - No symptoms at all to 6 - Death)
Rate of stent thrombosis [Month 6]
Rate of stent thrombosis
unsuccessful stent deployment [Baseline]
Rate of unsuccessful stent deployment
Concentration troubles [Baseline, Month 6]
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Sleep troubles [Baseline, Month 6]
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Headaches [Baseline, Month 6]
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Dizziness [Baseline, Month 6]
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Highly effective contraception for women of childbearing potential, maintained during research procedures
Affiliated or beneficiary of health insurance
Signed informed consent

Exclusion Criteria:

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
Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) < 30.
Patient who has a contraindication to MRI or angiography for whatever reason
Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period
Patient unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent
Patient under legal protection