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| Name | Class |
|---|---|
| French Ministry of Social Affairs and Health | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| venous stenting | Experimental | 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. |
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| no treatment | Active Comparator | standard care (no treatment) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous stenting | Device | venous stenting associated to antiaggregation protocol |
| |
| 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 |
| 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, Month 12, Month 24 |
| modified Rankin Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier BARREAU, MD | Contact | +33 556 79 56 04 | xavier.barreau@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Recruiting | Bordeaux | France |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care |
| Other |
observation: no treatment |
|
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, Month 12, Month 24 |
| unsuccessful stent deployment | Rate of unsuccessful stent deployment | Baseline |
| Concentration troubles | Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles | Baseline, Month 6, Month 12, Month 24 |
| Sleep troubles | Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles | Baseline, Month 6, Month 12, Month 24 |
| 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, Month 12, Month 24 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |