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Dural Arteriovenous FistulaLiquidNCT03524976

Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent

An observational study of Dural Arteriovenous Fistula, run by Dr. Markus Alfred Möhlenbruch at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Dural Arteriovenous Fistula
What is being tested?
Squid
How many people
50 participants
Where
7 sitesGermany
Study dates
1 Jan 2017to 29 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • DAVF with a Lariboisiere score < 3 • Pregnancy

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Klnikum Augsburg

    Augsburg, 86156

  • Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln

    Berlin, 12351

  • Charité-Universitätsmedizin Berlin

    Berlin, 13353

  • University Clinic Bochum

    Bochum

  • Alfried Krupp Krankenhaus Rüttenscheid

    Essen, 45131

  • Klinik für Neuroradiologie Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • LMU Klinikum der Universität München

    München, 81377

Other trials in Germany

About this study

Official title: 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

Read the 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 .

Being tested
Squid
Keywords
endovascular treatment, liquid embolization
Medical subject headings
Central Nervous System Vascular Malformations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SquidDevice

    Also called non-adhesive liquid embolic agent

    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.

Study groups in NCT03524976
Study groupRoleWhat they receive
Embolization with SquidAll 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
Receives: Device: Squid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity/Mortality

    number of patients with permanent morbidity or mortality

    Measured: 90-180 days after treatment

  2. Occlusion rate

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

    Measured: 90 -180 days after treatment

Secondary outcomes (11)

  1. DAVF anatomy

    Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification

    Measured: Baseline / day 0-1

  2. modified Rankin Score

    Baseline mRS

    Measured: Baseline / day 0-1

  3. Approach

    approach path (vessel)

    Measured: Treatment / day 1

  4. Feeders

    number of feeders embolized,

    Measured: Treatment / day 1

  5. Volume of Squid

    volume and concentration of SQUID™ injected at each embolization

    Measured: Treatment / day 1

  6. Ballons

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

    Measured: Treatment / day 1

  7. Coils

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

    Measured: Treatment / day 1

  8. Other

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

    Measured: Treatment / day 1

  9. Immediate Aneurysm Occlusion

    1. 50-99% occlusion
    2. < 50% occlusion

    Measured: Treatment / Day 1

  10. Follow-Up Aneurysm Occlusion

    1. 50-99% occlusion
    2. < 50% occlusion

    Measured: 90-180 days after treatment

  11. Functional health status

    based on modified Rankin Scale

    Measured: 90-180 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start1 Jan 2017
  3. Primary completion30 Jul 2020
  4. Study completion29 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03524976
Sponsor's protocol ID
Liquid
Acronym
Liquid
Status last verified
Oct 2020
First submitted
19 Mar 2018
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cognard C, Gobin YP, Pierot L, Bailly AL, Houdart E, Casasco A, Chiras J, Merland JJ. Cerebral dural arteriovenous fistulas: clinical and angiographic correlation with a revised classification of venous drainage. Radiology. 1995 Mar;194(3):671-80. doi: 10.1148/radiology.194.3.7862961.

    PubMed 7862961

  • Narayanan S. Endovascular management of intracranial dural arteriovenous fistulas. Neurol Clin. 2010 Nov;28(4):899-911. doi: 10.1016/j.ncl.2010.03.013.

    PubMed 20816269

  • Rammos S, Bortolotti C, Lanzino G. Endovascular management of intracranial dural arteriovenous fistulae. Neurosurg Clin N Am. 2014 Jul;25(3):539-49. doi: 10.1016/j.nec.2014.04.010. Epub 2014 Jun 2.

    PubMed 24994089

  • Li C, Yang X, Li Y, Jiang C, Wu Z. Endovascular Treatment of Intracranial Dural Arteriovenous Fistulas Presenting with Intracranial Hemorrhage in 46 Consecutive Patients: With Emphasis on Transarterial Embolization with Onyx. Clin Neuroradiol. 2016 Sep;26(3):301-8. doi: 10.1007/s00062-014-0362-y. Epub 2014 Dec 13.

    PubMed 25501269

  • Cognard C, Januel AC, Silva NA Jr, Tall P. Endovascular treatment of intracranial dural arteriovenous fistulas with cortical venous drainage: new management using Onyx. AJNR Am J Neuroradiol. 2008 Feb;29(2):235-41. doi: 10.3174/ajnr.A0817. Epub 2007 Nov 7.

    PubMed 17989374

  • Chiu AH, Aw G, Wenderoth JD. Double-lumen arterial balloon catheter technique for Onyx embolization of dural arteriovenous fistulas: initial experience. J Neurointerv Surg. 2014 Jun;6(5):400-3. doi: 10.1136/neurintsurg-2013-010768. Epub 2013 Jun 8.

    PubMed 23749795

  • Adamczyk P, Amar AP, Mack WJ, Larsen DW. Recurrence of "cured" dural arteriovenous fistulas after Onyx embolization. Neurosurg Focus. 2012 May;32(5):E12. doi: 10.3171/2012.2.FOCUS1224.

    PubMed 22537121

  • Ambekar S, Gaynor BG, Peterson EC, Elhammady MS. Long-term angiographic results of endovascularly "cured" intracranial dural arteriovenous fistulas. J Neurosurg. 2016 Apr;124(4):1123-7. doi: 10.3171/2015.3.JNS1558. Epub 2015 Sep 25.

    PubMed 26406789

  • Akmangit I, Daglioglu E, Kaya T, Alagoz F, Sahinoglu M, Peker A, Derakshani S, Dede D, Belen D, Arat A. Preliminary experience with squid: a new liquid embolizing agent for AVM, AV fistulas and tumors. Turk Neurosurg. 2014;24(4):565-70. doi: 10.5137/1019-5149.JTN.11179-14.0.

    PubMed 25050683

  • Abud TG, Nguyen A, Saint-Maurice JP, Abud DG, Bresson D, Chiumarulo L, Enesi E, Houdart E. The use of Onyx in different types of intracranial dural arteriovenous fistula. AJNR Am J Neuroradiol. 2011 Dec;32(11):2185-91. doi: 10.3174/ajnr.A2702. Epub 2011 Sep 29.

    PubMed 21960490

  • Chandra RV, Leslie-Mazwi TM, Mehta BP, Yoo AJ, Rabinov JD, Pryor JC, Hirsch JA, Nogueira RG. Transarterial onyx embolization of cranial dural arteriovenous fistulas: long-term follow-up. AJNR Am J Neuroradiol. 2014 Sep;35(9):1793-7. doi: 10.3174/ajnr.A3938. Epub 2014 Apr 17.

    PubMed 24742807

  • Gross BA, Albuquerque FC, Moon K, McDougall CG. Evolution of treatment and a detailed analysis of occlusion, recurrence, and clinical outcomes in an endovascular library of 260 dural arteriovenous fistulas. J Neurosurg. 2017 Jun;126(6):1884-1893. doi: 10.3171/2016.5.JNS16331. Epub 2016 Sep 2.

    PubMed 27588586

  • Gallas S, Drouineau J, Gabrillargues J, Pasco A, Cognard C, Pierot L, Herbreteau D. Feasibility, procedural morbidity and mortality, and long-term follow-up of endovascular treatment of 321 unruptured aneurysms. AJNR Am J Neuroradiol. 2008 Jan;29(1):63-8. doi: 10.3174/ajnr.A0757. Epub 2007 Oct 9.

    PubMed 17925369

  • Hsu YH, Lee CW, Liu HM, Wang YH, Chen YF. Endovascular treatment and computed imaging follow-up of 14 anterior condylar dural arteriovenous fistulas. Interv Neuroradiol. 2014 May-Jun;20(3):368-77. doi: 10.15274/INR-2014-10028. Epub 2014 Jun 17.

    PubMed 24976101

  • Long XA, Karuna T, Zhang X, Luo B, Duan CZ. Onyx 18 embolisation of dural arteriovenous fistula via arterial and venous pathways: preliminary experience and evaluation of the short-term outcomes. Br J Radiol. 2012 Aug;85(1016):e395-403. doi: 10.1259/bjr/25192972. Epub 2012 Feb 28.

    PubMed 22374275

Questions about this trial

What is this clinical trial studying?

An observational study of Dural Arteriovenous Fistula, run by Dr. Markus Alfred Möhlenbruch at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity/Mortality (time frame: 90-180 days after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03524976, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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