Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent
- Conditions
- Dural Arteriovenous Fistula
- Interventions
- Device: Squid
- Registration Number
- NCT03524976
- Lead Sponsor
- Dr. Markus Alfred Möhlenbruch
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
-
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.
- DAVF with a Lariboisiere score < 3 • Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Embolization with Squid Squid 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Follow-Up Aneurysm Occlusion 90-180 days after treatment 1. 50-99% occlusion
2. \< 50% occlusionFunctional health status 90-180 days after treatment based on modified Rankin Scale
Feeders Treatment / day 1 number of feeders embolized,
DAVF anatomy Baseline / day 0-1 Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification
modified Rankin Score Baseline / day 0-1 Baseline mRS
Approach Treatment / day 1 approach path (vessel)
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
Coils Treatment / day 1 If complete occlusion was not achieved using Squid: Binary Outcome: use of coils or no use of coils
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
Trial Locations
- Locations (7)
Klnikum Augsburg
🇩🇪Augsburg, Germany
Alfried Krupp Krankenhaus Rüttenscheid
🇩🇪Essen, Germany
University Clinic Bochum
🇩🇪Bochum, Germany
LMU Klinikum der Universität München
🇩🇪München, Germany
Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
Klinik für Neuroradiologie Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Charité-Universitätsmedizin Berlin
🇩🇪Berlin, Germany