Trials / Completed
CompletedNCT03524976
Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent
LIQUID - Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent, A Non-interventional, Observational, Prospective and Multi-center Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Dr. Markus Alfred Möhlenbruch · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Squid | 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. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2020-07-30
- Completion
- 2020-08-29
- First posted
- 2018-05-15
- Last updated
- 2020-10-09
Locations
7 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03524976. Inclusion in this directory is not an endorsement.