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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulsatile Tinnitus
• Intervention / Treatment: Device: Venous stenting; Other: Standard of care

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xavier BARREAU, MD; Phone Number: +33 556 79 56 04; Email: xavier.barreau@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux
    • Contact: Xavier Barreau, MD; Phone Number: 33556795604; Email: xavier.barreau@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
modified Rankin Scale	mRS Neurological score (from 0 - No symptoms at all to 6 - Death)	Baseline, Month 6
Rate of stent thrombosis	Rate of stent thrombosis	Month 6
unsuccessful stent deployment	Rate of unsuccessful stent deployment	Baseline
Composite criteria with angiographic OR clinical modification	Composite criteria with angiographic (Cognard's classification) OR clinical modification (13 points improvment on THI scoring or THI score equal to 0)	Month 6
Concentration troubles	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6
Sleep troubles	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6
Headaches	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6
Dizziness	Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles	Baseline, Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: French Ministry of Social Affairs and Health

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Dural arteriovenous fistulae; Pulsatile tinnitus; Venous Stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Congenital Abnormalities; Otorhinolaryngologic Diseases; Ear Diseases; Pathological Conditions, Anatomical; Sensation Disorders; Cardiovascular Abnormalities; Nervous System Malformations; Vascular Malformations; Hearing Disorders; Arteriovenous Malformations; Vascular Fistula; Fistula; Tinnitus; Arteriovenous Fistula; Central Nervous System Vascular Malformations
• Other Study ID Numbers: CHUBX 2022/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No