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

Primary Purpose

Pulsatile Tinnitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Venous stenting
Standard of care
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulsatile Tinnitus focused on measuring Dural arteriovenous fistulae, Pulsatile tinnitus, Venous Stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

venous stenting

no treatment

Arm Description

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.

standard care (no treatment)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
modified Rankin Scale
mRS Neurological score (from 0 - No symptoms at all to 6 - Death)
Rate of stent thrombosis
Rate of stent thrombosis
unsuccessful stent deployment
Rate of unsuccessful stent deployment
Concentration troubles
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Sleep troubles
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Headaches
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Dizziness
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles

Full Information

First Posted
December 28, 2022
Last Updated
January 13, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
French Ministry of Social Affairs and Health
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1. Study Identification

Unique Protocol Identification Number
NCT05679271
Brief Title
Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
Acronym
INVENT
Official Title
Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
French Ministry of Social Affairs and Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulsatile Tinnitus
Keywords
Dural arteriovenous fistulae, Pulsatile tinnitus, Venous Stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
venous stenting
Arm Type
Experimental
Arm Description
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.
Arm Title
no treatment
Arm Type
Active Comparator
Arm Description
standard care (no treatment)
Intervention Type
Device
Intervention Name(s)
Venous stenting
Intervention Description
venous stenting associated to antiaggregation protocol
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
observation: no treatment
Primary Outcome Measure Information:
Title
Cognard's classification grade
Description
Cognard's classification status : from type I (Anterograde drainage into venous sinus) to Type V (Drainage into the spinal perimedullary veins)
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
THI score
Description
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)
Time Frame
Baseline, Month 6
Title
Composite criteria with angiographic OR clinical modification
Description
Composite criteria with angiographic (Cognard's classification) OR clinical modification (13 points improvment on THI scoring or THI score equal to 0)
Time Frame
Month 6
Title
modified Rankin Scale
Description
mRS Neurological score (from 0 - No symptoms at all to 6 - Death)
Time Frame
Baseline, Month 6
Title
Rate of stent thrombosis
Description
Rate of stent thrombosis
Time Frame
Month 6
Title
unsuccessful stent deployment
Description
Rate of unsuccessful stent deployment
Time Frame
Baseline
Title
Concentration troubles
Description
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time Frame
Baseline, Month 6
Title
Sleep troubles
Description
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time Frame
Baseline, Month 6
Title
Headaches
Description
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time Frame
Baseline, Month 6
Title
Dizziness
Description
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier BARREAU, MD
Phone
+33 556 79 56 04
Email
xavier.barreau@chu-bordeaux.fr
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Barreau, MD
Phone
33556795604
Email
xavier.barreau@chu-bordeaux.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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