The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™ in the embolization of Dural Arteriovenous Fistula
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 .
Study Type
OBSERVATIONAL
Enrollment
50
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.
Klnikum Augsburg
Augsburg, Germany
Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln
Berlin, Germany
Charité-Universitätsmedizin Berlin
Berlin, Germany
University Clinic Bochum
Bochum, Germany
Morbidity/Mortality
number of patients with permanent morbidity or mortality
Time frame: 90-180 days after treatment
Occlusion rate
number of patients with complete occlusion of the treated Dural Arteriovenous Fistula
Time frame: 90 -180 days after treatment
DAVF anatomy
Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification
Time frame: Baseline / day 0-1
modified Rankin Score
Baseline mRS
Time frame: Baseline / day 0-1
Approach
approach path (vessel)
Time frame: Treatment / day 1
Feeders
number of feeders embolized,
Time frame: Treatment / day 1
Volume of Squid
volume and concentration of SQUID™ injected at each embolization
Time frame: Treatment / day 1
Ballons
Binary: for access to DAVF was a balloon catheter used / no balloon used
Time frame: Treatment / day 1
Coils
If complete occlusion was not achieved using Squid: Binary Outcome: use of coils or no use of coils
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alfried Krupp Krankenhaus Rüttenscheid
Essen, Germany
Klinik für Neuroradiologie Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
LMU Klinikum der Universität München
München, Germany
Time frame: Treatment / day 1
Other
If complete occlusion was not achieved using Squid: Binary Outcome: use of other embolization agent / no other agent used
Time frame: Treatment / day 1
Immediate Aneurysm Occlusion
1. 50-99% occlusion 2. \< 50% occlusion
Time frame: Treatment / Day 1
Follow-Up Aneurysm Occlusion
1. 50-99% occlusion 2. \< 50% occlusion
Time frame: 90-180 days after treatment
Functional health status
based on modified Rankin Scale
Time frame: 90-180 days after treatment