Clinical trial NCT03524976: Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent
Official title: LIQUID - Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent, A Non-interventional, Observational, Prospective and Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dural Arteriovenous Fistula
Keywords: endovascular treatment
liquid embolization
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
First posted: 2018-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Dural Arteriovenous Fistulas who will be 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 patient cohort will include patients with DAVFs who had not undergone any previous treatment with an embolic agent whatsoever.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity/Mortality
timeFrame: 90-180 days after treatment
measure: Occlusion rate
timeFrame: 90 -180 days after treatment
Secondary outcomes:
measure: DAVF anatomy
timeFrame: Baseline / day 0-1
measure: modified Rankin Score
timeFrame: Baseline / day 0-1
measure: Approach
timeFrame: Treatment / day 1
measure: Feeders
timeFrame: Treatment / day 1
measure: Volume of Squid
timeFrame: Treatment / day 1
measure: Ballons
timeFrame: Treatment / day 1
measure: Coils
timeFrame: Treatment / day 1
measure: Other
timeFrame: Treatment / day 1
measure: Immediate Aneurysm Occlusion
timeFrame: Treatment / Day 1
measure: Follow-Up Aneurysm Occlusion
timeFrame: 90-180 days after treatment
measure: Functional health status
timeFrame: 90-180 days after treatment
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klnikum Augsburg
city: Berlin
country: Germany
facility: Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: University Clinic Bochum
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus Rüttenscheid
city: Freiburg
country: Germany
facility: Klinik für Neuroradiologie Universitätsklinikum Freiburg
city: München
country: Germany
facility: LMU Klinikum der Universität München
Study officials:
affiliation: University Hospital Heidelberg
name: Markus Moehlenbruch, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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