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Completed

NCT Number: NCT03524976

Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent

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

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Key information

Conditions

Dural Arteriovenous Fistula Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Vascular Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klnikum Augsburg, Augsburg, Germany

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Squid

Device

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.

Other names: non-adhesive liquid embolic agent

Primary outcomes

  1. Morbidity/Mortality

    Time frame: 90-180 days after treatment

    number of patients with permanent morbidity or mortality

  2. Occlusion rate

    Time frame: 90 -180 days after treatment

    number of patients with complete occlusion of the treated Dural Arteriovenous Fistula

Secondary outcomes

  1. DAVF anatomy

    Time frame: Baseline / day 0-1

    Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification

  2. modified Rankin Score

    Time frame: Baseline / day 0-1

    Baseline mRS

  3. Approach

    Time frame: Treatment / day 1

    approach path (vessel)

  4. Feeders

    Time frame: Treatment / day 1

    number of feeders embolized,

  5. Volume of Squid

    Time frame: Treatment / day 1

    volume and concentration of SQUID™ injected at each embolization

  6. Ballons

    Time frame: Treatment / day 1

    Binary: for access to DAVF was a balloon catheter used / no balloon used

  7. Coils

    Time frame: Treatment / day 1

    If complete occlusion was not achieved using Squid: Binary Outcome: use of coils or no use of coils

  8. Other

    Time frame: Treatment / day 1

    If complete occlusion was not achieved using Squid: Binary Outcome: use of other embolization agent / no other agent used

  9. Immediate Aneurysm Occlusion

    Time frame: Treatment / Day 1

    • 50-99% occlusion
    • < 50% occlusion

  10. Follow-Up Aneurysm Occlusion

    Time frame: 90-180 days after treatment

    • 50-99% occlusion
    • < 50% occlusion

  11. Functional health status

    Time frame: 90-180 days after treatment

    based on modified Rankin Scale

Sponsors and collaborators

Lead sponsor

Dr. Markus Alfred Möhlenbruch

Other

Collaborators

  • University Hospital Schleswig-Holstein

Registry information

Official study title

LIQUID - Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent, A Non-interventional, Observational, Prospective and Multi-center Study

Acronym: Liquid

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 15, 2018
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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