Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent

Study Overview
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Brief Summary
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The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™ in the embolization of Dural Arteriovenous Fistula

Detailed Description
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Traditionally, there are two therapeutic options for the treatment of Dural Arteriovenous Fistula (DAVF): (1) the surgical approach consisting of craniotomy and ligation of the vein and (2) the endovascular approach with embolization of shunting zone. Onyx™ (EVOH (Ethylene Vinyl Alcohol) in solution in an organic solvent, DMSO (Dimethyl Sulfoxide), is the main embolic agent used for the endovascular treatment of DAVF. During the occlusion procedure with Onyx™, residual malformed compartments become gradually less visible on x-ray to the operator, due to the high radiopacity of Onyx™, resulting in a potential risk during treatment. Moreover, viscosity is frequently not as low as required to penetrate the shunt.Thus, development a new embolization system with lower radiopacity and lower viscosity to achieve improved occlusion is needed. SQUID™ is a new liquid embolic agent, with variable radiopacity and viscosity. The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™ in the embolization of DAVFs .

Official Title
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LIQUID - Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent, A Non-interventional, Observational, Prospective and Multi-center Study

Conditions
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Dural Arteriovenous Fistula

Intervention / Treatment
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* Device: Squid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dural Arteriovenous Fistula requiring endovascular treatment with a Lariboisiere score between 3 - 5 Intended usage of SQUID™ The patient agrees with the clinical data collection and medical file access. Exclusion Criteria: DAVF with a Lariboisiere score < 3 • Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Embolization with Squid<br>All patients with DAVFs are treated with SQUID™ aiming at complete occlusion of the fistula. Each participating center will include patients with DAVFs in whom the liquid embolic agent SQUID™ is planned to be used consecutively in the study. The | Device: Squid<br>* SQUID™ is injected into the vascular site to be treated, under fluoroscopic control. DMSO dissipates in the blood and causes precipitation of EVOH in which the tantalum powder is trapped. It then forms a consistent spongy embolus. This embolus solidifies from the outside inwardly while moving distally in the vessel. The non-adhesive character of the embolus allows slow and controlled injections while leaving in place the microcatheter.<br>* Other names: non-adhesive liquid embolic agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity/Mortality | number of patients with permanent morbidity or mortality | 90-180 days after treatment | 
| Occlusion rate | number of patients with complete occlusion of the treated Dural Arteriovenous Fistula | 90 -180 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAVF anatomy | Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification | Baseline / day 0-1 | 
| modified Rankin Score | Baseline mRS | Baseline / day 0-1 | 
| Approach | approach path (vessel) | Treatment / day 1 | 
| Feeders | number of feeders embolized, | Treatment / day 1 | 
| Volume of Squid | volume and concentration of SQUID™ injected at each embolization | Treatment / day 1 | 
| Ballons | Binary: for access to DAVF was a balloon catheter used / no balloon used | Treatment / day 1 | 
| Coils | If complete occlusion was not achieved using Squid: Binary Outcome: use of coils or no use of coils | Treatment / day 1 | 
| Other | If complete occlusion was not achieved using Squid: Binary Outcome: use of other embolization agent / no other agent used | Treatment / day 1 | 
| Immediate Aneurysm Occlusion | 50-99% occlusion < 50% occlusion | Treatment / Day 1 | 
| Follow-Up Aneurysm Occlusion | 50-99% occlusion < 50% occlusion | 90-180 days after treatment | 
| Functional health status | based on modified Rankin Scale | 90-180 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovascular treatment, liquid embolization