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

Pulsatile Tinnitus Clinical Trial

— INVENT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05679271
• Other study ID #: CHUBX 2022/20
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: Xavier BARREAU, MD
• Phone: +33 556 79 56 04
• Email: xavier.barreau[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• 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

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Pulsatile Tinnitus
• Tinnitus

Intervention

Device:
• Venous stenting
venous stenting associated to antiaggregation protocol

Other:
• Standard of care
observation: no treatment

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	French Ministry of Social Affairs and Health

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	THI score	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)	Baseline, Month 6, Month 12, Month 24
Secondary	modified Rankin Scale	mRS Neurological score (from 0 - No symptoms at all to 6 - Death)	Baseline, Month 6
Secondary	Rate of stent thrombosis	Rate of stent thrombosis	Month 6, Month 12, Month 24
Secondary	unsuccessful stent deployment	Rate of unsuccessful stent deployment	Baseline
Secondary	Concentration troubles	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6, Month 12, Month 24
Secondary	Sleep troubles	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6, Month 12, Month 24
Secondary	Headaches	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6
Secondary	Dizziness	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6, Month 12, Month 24