Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent
NCT ID: NCT03524976
Last Updated: 2020-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2017-01-01
2020-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intended usage of SQUID™
* The patient agrees with the clinical data collection and medical file access.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Dr. Markus Alfred Möhlenbruch
OTHER
Responsible Party
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Dr. Markus Alfred Möhlenbruch
Principle Investigator
Principal Investigators
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Markus Moehlenbruch, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg
Locations
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Klnikum Augsburg
Augsburg, , Germany
Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln
Berlin, , Germany
Charité-Universitätsmedizin Berlin
Berlin, , Germany
University Clinic Bochum
Bochum, , Germany
Alfried Krupp Krankenhaus Rüttenscheid
Essen, , Germany
Klinik für Neuroradiologie Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
LMU Klinikum der Universität München
München, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Liquid
Identifier Type: -
Identifier Source: org_study_id
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