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Pulsatile TinnitusINVENTNCT05679271

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

A study testing Venous stenting in people with Pulsatile Tinnitus, run by University Hospital, Bordeaux at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulsatile Tinnitus
What is being tested?
Venous stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteFrance
Study dates
22 Aug 2024to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xavier BARREAU, MD contact

+33 556 79 56 04

xavier.barreau@chu-bordeaux.fr

France1 site, 1 recruiting

  • CHU Bordeaux

    Bordeaux

    Xavier Barreau, MD, 33556795604, xavier.barreau@chu-bordeaux.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Venous stenting, Standard of care
Keywords
Dural arteriovenous fistulae, Pulsatile tinnitus, Venous Stenting
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venous stentingDevice

    venous stenting associated to antiaggregation protocol

  • Standard of careOther

    observation: no treatment

Study groups in NCT05679271
Study groupRoleWhat they receive
venous stentingExperimentalVenous 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.
Receives: Device: Venous stenting
no treatmentActive comparatorstandard care (no treatment)
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Month 6

Secondary outcomes (8)

  1. 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)

    Measured: Baseline, Month 6, Month 12, Month 24

  2. modified Rankin Scale

    mRS Neurological score (from 0 - No symptoms at all to 6 - Death)

    Measured: Baseline, Month 6

  3. Rate of stent thrombosis

    Rate of stent thrombosis

    Measured: Month 6, Month 12, Month 24

  4. unsuccessful stent deployment

    Rate of unsuccessful stent deployment

    Measured: Baseline

  5. Concentration troubles

    Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles

    Measured: Baseline, Month 6, Month 12, Month 24

  6. Sleep troubles

    Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles

    Measured: Baseline, Month 6, Month 12, Month 24

  7. Headaches

    Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles

    Measured: Baseline, Month 6

  8. Dizziness

    Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles

    Measured: Baseline, Month 6, Month 12, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start22 Aug 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05679271
Sponsor's protocol ID
CHUBX 2022/20
Acronym
INVENT
Status last verified
Feb 2025
First submitted
28 Dec 2022
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Venous stenting in people with Pulsatile Tinnitus, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xavier BARREAU, MD (+33 556 79 56 04, xavier.barreau@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognard's classification grade (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05679271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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