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| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein | OTHER |
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The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™ in the embolization of Dural Arteriovenous Fistula
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| DAVF anatomy | Anatomical description of the Dural Arteriovenous Fistula using Lariboisiere classification | Baseline / day 0-1 |
| modified Rankin Score | Baseline mRS |
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Inclusion Criteria:
Dural Arteriovenous Fistula requiring endovascular treatment with a Lariboisiere score between 3 - 5
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Markus Moehlenbruch, PD Dr. | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klnikum Augsburg | Augsburg | 86156 | Germany | |||
| Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7862961 | Background | 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. | |
| 20816269 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 28, 2023 | |
| Reset | May 10, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 28, 2023 | May 10, 2024 |
| ID | Term |
|---|---|
| D020785 | Central Nervous System Vascular Malformations |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
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|
|
| Baseline / day 0-1 |
| Approach | approach path (vessel) | Treatment / day 1 |
| Feeders | number of feeders embolized, | Treatment / day 1 |
| Volume of Squid | volume and concentration of SQUID™ injected at each embolization | Treatment / day 1 |
| Ballons | Binary: for access to DAVF was a balloon catheter used / no balloon used | Treatment / day 1 |
| Coils | If complete occlusion was not achieved using Squid: Binary Outcome: use of coils or no use of coils | Treatment / day 1 |
| Other | 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 |
| Treatment / Day 1 |
| Follow-Up Aneurysm Occlusion |
| 90-180 days after treatment |
| Functional health status | based on modified Rankin Scale | 90-180 days after treatment |
| Berlin |
| 12351 |
| Germany |
| Charité-Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| University Clinic Bochum | Bochum | Germany |
| Alfried Krupp Krankenhaus Rüttenscheid | Essen | 45131 | Germany |
| Klinik für Neuroradiologie Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| LMU Klinikum der Universität München | München | 81377 | Germany |
| 24994089 | 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. |
| 25501269 | 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. |
| 17989374 | 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. |
| 23749795 | 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. |
| 22537121 | 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. |
| 26406789 | 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. |
| 25050683 | 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. |
| 21960490 | 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. |
| 24742807 | 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. |
| 27588586 | 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. |
| 17925369 | 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. |
| 24976101 | 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. |
| 22374275 | 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. |
| 21998110 | 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. |
| 20395390 | 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. |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |