Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent

Dural Arteriovenous Fistula Clinical Trial

— Liquid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524976
• Other study ID #: Liquid
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: August 29, 2020

Study information

• Verified date: October 2020
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 29, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Dural Arteriovenous Fistula
• Fistula

Intervention

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.

Locations

Country	Name	City	State
Germany	Klnikum Augsburg	Augsburg
Germany	Charité-Universitätsmedizin Berlin	Berlin
Germany	Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln	Berlin
Germany	University Clinic Bochum	Bochum
Germany	Alfried Krupp Krankenhaus Rüttenscheid	Essen
Germany	Klinik für Neuroradiologie Universitätsklinikum Freiburg	Freiburg
Germany	LMU Klinikum der Universität München	München

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Markus Alfred Möhlenbruch	University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Nov 7. — View Citation

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. Epub 2007 Oct 9. — View Citation

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. — View Citation

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/NRJ-2014-10028. Epub 2014 Jun 17. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

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