Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent

NCT03524976 | Completed

• 1 other identifier: Liquid
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 7

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

Conditions

Dural Arteriovenous Fistula

Keywords

endovascular treatment; liquid embolization

Outcome Measures

Primary Outcomes (2)

• Morbidity/Mortality

  number of patients with permanent morbidity or mortality

  90-180 days after treatment

• Occlusion rate

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

  90 -180 days after treatment

Secondary Outcomes (11)

• DAVF anatomy

  Baseline / day 0-1

• modified Rankin Score

  Baseline / day 0-1

• Approach

  Treatment / day 1

• Feeders

  Treatment / day 1

• Volume of Squid

  Treatment / day 1

Study Arms (1)

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

Interventions

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.

Also known as: non-adhesive liquid embolic agent

Embolization with Squid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• DAVF with a Lariboisiere score \< 3 • Pregnancy

Sponsors & Collaborators

• Dr. Markus Alfred Möhlenbruch: lead
• University Hospital Schleswig-Holstein: collaborator

Study Sites (7)

Klnikum Augsburg

Augsburg, 86156, Germany

Location

Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Charité-Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

University Clinic Bochum

Bochum, Germany

Location

Alfried Krupp Krankenhaus Rüttenscheid

Essen, 45131, Germany

Location

Klinik für Neuroradiologie Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

LMU Klinikum der Universität München

München, 81377, Germany

Location

Related Publications (17)

• 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.

  PMID: 7862961 BACKGROUND

• 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.

  PMID: 20816269 BACKGROUND

• 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.

  PMID: 24994089 BACKGROUND

• 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.

  PMID: 25501269 BACKGROUND

• 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.

  PMID: 17989374 BACKGROUND

• 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.

  PMID: 23749795 BACKGROUND

• 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.

  PMID: 22537121 BACKGROUND

• 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.

  PMID: 26406789 BACKGROUND

• 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.

  PMID: 25050683 BACKGROUND

• 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.

  PMID: 21960490 BACKGROUND

• 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.

  PMID: 24742807 BACKGROUND

• 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.

  PMID: 27588586 BACKGROUND

• 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.

  PMID: 17925369 BACKGROUND

• 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.

  PMID: 24976101 BACKGROUND

• 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.

  PMID: 22374275 BACKGROUND

• Maimon S, Nossek E, Strauss I, Blumenthal D, Frolov V, Ram Z. Transarterial treatment with Onyx of intracranial dural arteriovenous fistula with cortical drainage in 17 patients. AJNR Am J Neuroradiol. 2011 Dec;32(11):2180-4. doi: 10.3174/ajnr.A2728. Epub 2011 Oct 13.

  PMID: 21998110 BACKGROUND

• van Rooij WJ, Sluzewski M. Curative embolization with Onyx of dural arteriovenous fistulas with cortical venous drainage. AJNR Am J Neuroradiol. 2010 Sep;31(8):1516-20. doi: 10.3174/ajnr.A2101. Epub 2010 Apr 15.

  PMID: 20395390 BACKGROUND

MeSH Terms

Conditions

Central Nervous System Vascular Malformations

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Markus Moehlenbruch, PD Dr.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: May 15, 2018
• Study Start: January 1, 2017
• Primary Completion: July 30, 2020
• Study Completion: August 29, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)