Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent

Dr. Markus Alfred Möhlenbruch

Status: Completed

Conditions: Dural Arteriovenous Fistula

Treatments: Device: Squid

Study type: Observational

Funder types: Other

Identifiers

NCT03524976

Liquid

Details and patient eligibility

About

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

Full 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 .

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Embolization with Squid

Description:

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

Treatment:

Device: Squid