Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent (Liquid)

October 8, 2020 updated by: Dr. Markus Alfred Möhlenbruch

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86156
        • Klnikum Augsburg
      • Berlin, Germany, 12351
        • Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln
      • Berlin, Germany, 13353
        • Charite-Universitatsmedizin Berlin
      • Bochum, Germany
        • University Clinic Bochum
      • Essen, Germany, 45131
        • Alfried Krupp Krankenhaus Rüttenscheid
      • Freiburg, Germany, 79106
        • Klinik für Neuroradiologie Universitätsklinikum Freiburg
      • München, Germany, 81377
        • LMU Klinikum der Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Embolization with 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
Device: Squid

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity/Mortality
Time Frame: 90-180 days after treatment
number of patients with permanent morbidity or mortality
90-180 days after treatment
Occlusion rate
Time Frame: 90 -180 days after treatment
number of patients with complete occlusion of the treated Dural Arteriovenous Fistula
90 -180 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAVF anatomy
Time Frame: Baseline / day 0-1
Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification
Baseline / day 0-1
modified Rankin Score
Time Frame: Baseline / day 0-1
Baseline mRS
Baseline / day 0-1
Approach
Time Frame: Treatment / day 1
approach path (vessel)
Treatment / day 1
Feeders
Time Frame: Treatment / day 1
number of feeders embolized,
Treatment / day 1
Volume of Squid
Time Frame: Treatment / day 1
volume and concentration of SQUID™ injected at each embolization
Treatment / day 1
Ballons
Time Frame: Treatment / day 1
Binary: for access to DAVF was a balloon catheter used / no balloon used
Treatment / day 1
Coils
Time Frame: Treatment / day 1
If complete occlusion was not achieved using Squid: Binary Outcome: use of coils or no use of coils
Treatment / day 1
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
Treatment / day 1
Immediate Aneurysm Occlusion
Time Frame: Treatment / Day 1
  1. 50-99% occlusion
  2. < 50% occlusion
Treatment / Day 1
Follow-Up Aneurysm Occlusion
Time Frame: 90-180 days after treatment
  1. 50-99% occlusion
  2. < 50% occlusion
90-180 days after treatment
Functional health status
Time Frame: 90-180 days after treatment
based on modified Rankin Scale
90-180 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Markus Alfred Möhlenbruch

Collaborators

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Markus Moehlenbruch, PD Dr., University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

August 29, 2020

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liquid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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