Dural Arteriovenous Fistula
Conditions
Keywords
endovascular treatment, liquid embolization
Brief summary
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
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 .
Interventions
DEVICESquid
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.
Sponsors
University Hospital Schleswig-Holstein
Dr. Markus Alfred Möhlenbruch
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity/Mortality | 90-180 days after treatment | number of patients with permanent morbidity or mortality |
| Occlusion rate | 90 -180 days after treatment | number of patients with complete occlusion of the treated Dural Arteriovenous Fistula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Approach | Treatment / day 1 | approach path (vessel) |
| Feeders | Treatment / day 1 | number of feeders embolized, |
| Volume of Squid | Treatment / day 1 | volume and concentration of SQUID™ injected at each embolization |
| Ballons | Treatment / day 1 | Binary: for access to DAVF was a balloon catheter used / no balloon used |
| DAVF anatomy | Baseline / day 0-1 | Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification |
| Other | Treatment / day 1 | If complete occlusion was not achieved using Squid: Binary Outcome: use of other embolization agent / no other agent used |
| Immediate Aneurysm Occlusion | Treatment / Day 1 | 1. 50-99% occlusion 2. \< 50% occlusion |
| Follow-Up Aneurysm Occlusion | 90-180 days after treatment | 1. 50-99% occlusion 2. \< 50% occlusion |
| Functional health status | 90-180 days after treatment | based on modified Rankin Scale |
| Coils | Treatment / day 1 | If complete occlusion was not achieved using Squid: Binary Outcome: use of coils or no use of coils |
| modified Rankin Score | Baseline / day 0-1 | Baseline mRS |
Countries
Germany
Outcome results
None listed