Study Results
Results pending
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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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-06-30
Study Completion Date
2015-06-30
Brief Summary
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The purpose of this prospective registry is to determine if patients harboring intracranial aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and blood plasma.
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A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms
NCT03133624
Intracranial Aneurysm
UNKNOWN
Detailed Description
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To design a registry to evaluate the wall of intracranial aneurysms during open surgical clipping by direct photographic appearance, wall biopsy samples, CSF and blood plasma fluid collection (Interleukins; IL-8/ Matrix Metalloproteinase; MMP-9) for complete evaluation and comparison.
The focus of the registry will be to determine the presence of aneurysmal wall defects, mural clot, atherosclerotic and atheroma, wall permeability and delamination. These findings will then be correlated to the collected CSF and blood values to determine if there is any direct features of the aneurysm wall that would predict any of the reported post embolic syndromes. The collected data can also be correlated to the peroperative imaging, (MRI, CT and Angiogram).
The focus of the registry will be to determine the presence of aneurysmal wall defects, mural clot, atherosclerotic and atheroma, wall permeability and delamination. These findings will then be correlated to the collected CSF and blood values to determine if there is any direct features of the aneurysm wall that would predict any of the reported post embolic syndromes. The collected data can also be correlated to the peroperative imaging, (MRI, CT and Angiogram).
Conditions
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Brain Aneurysm
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Aneurysm
Group Type
EXPERIMENTAL
Surgical Clipping of Aneurysm
Intervention Type
PROCEDURE
Surgical clipping of intracranial aneurysm
Interventions
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Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Patient \> 18 years but \< 80 years of age
* Patient with an unruptured Intracranial aneurysm 8mm or larger
* Patient that surgical exposure and clipping will be the primary treatment option
* Patient with an unruptured Intracranial aneurysm 8mm or larger
* Patient that surgical exposure and clipping will be the primary treatment option
Exclusion Criteria
* Any patient that has a ruptured intracranial aneurysm
* Any Pediatric patients
* Any patient presenting with any pre-treatment intracranial lesions
* Vascular malformations
* Hemorrhage
* Normal Pressure Hydrocephalus
* Obstructive Hydrocephalus
* White matter disease
* Tumors
* Trauma
* Other vascular type lesions
* Any meningitis type symptoms
* Medical or surgical co-morbidities such that the patient's life expectancy is less than 1 year
* Inability to obtain consent
* Any Pediatric patients
* Any patient presenting with any pre-treatment intracranial lesions
* Vascular malformations
* Hemorrhage
* Normal Pressure Hydrocephalus
* Obstructive Hydrocephalus
* White matter disease
* Tumors
* Trauma
* Other vascular type lesions
* Any meningitis type symptoms
* Medical or surgical co-morbidities such that the patient's life expectancy is less than 1 year
* Inability to obtain consent
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Albany Medical College
OTHER
Sponsor Role
collaborator
Northwestern University
OTHER
Sponsor Role
collaborator
Stony Brook University
OTHER
Sponsor Role
collaborator
Royal University Hospital Foundation
OTHER
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
collaborator
Providence Health & Services
OTHER
Sponsor Role
collaborator
University of Illinois at Chicago
OTHER
Sponsor Role
collaborator
Vanderbilt University
OTHER
Sponsor Role
collaborator
Methodist Health System
OTHER
Sponsor Role
collaborator
Medical University of South Carolina
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Henry Woo
Role: PRINCIPAL_INVESTIGATOR
SUNY - Stonybrook
Arthur Adam, MD
Role: PRINCIPAL_INVESTIGATOR
Baptist Hospital
Mike Kelly
Role: PRINCIPAL_INVESTIGATOR
Royal University Hospital Foundation
Locations
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Northwestern University
Chicago, Illinois, United States
Site Status
University Of Illinois
Chicago, Illinois, United States
Site Status
Goodman Campbell
Indianapolis, Indiana, United States
Site Status
Albany Medical Center
Albany, New York, United States
Site Status
SUNY - Stonybrook University Medical Center
Stony Brook, New York, United States
Site Status
Providence Health
Portland, Oregon, United States
Site Status
Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
Methodist Healthcare - Memphis
Memphis, Tennessee, United States
Site Status
Vanderbilt University
Nashville, Tennessee, United States
Site Status
Royal University Hospital
Saskatoon, Ontario, Canada
Site Status
Countries
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United States
Canada
References
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Weir B. Unruptured intracranial aneurysms: a review. J Neurosurg. 2002 Jan;96(1):3-42. doi: 10.3171/jns.2002.96.1.0003.
Reference Type
BACKGROUND
Ronkainen A, Hernesniemi J. Subarachnoid haemorrhage of unknown aetiology. Acta Neurochir (Wien). 1992;119(1-4):29-34. doi: 10.1007/BF01541778.
Reference Type
BACKGROUND
STEHBENS WE. ANEURYSMS AND ANATOMICAL VARIATION OF CEREBRAL ARTERIES. Arch Pathol. 1963 Jan;75:45-64. No abstract available.
Reference Type
BACKGROUND
Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.
Reference Type
BACKGROUND
Juvela S, Hillbom M, Numminen H, Koskinen P. Cigarette smoking and alcohol consumption as risk factors for aneurysmal subarachnoid hemorrhage. Stroke. 1993 May;24(5):639-46. doi: 10.1161/01.str.24.5.639.
Reference Type
BACKGROUND
Juvela S. Prehemorrhage risk factors for fatal intracranial aneurysm rupture. Stroke. 2003 Aug;34(8):1852-7. doi: 10.1161/01.STR.0000080380.56799.DD. Epub 2003 Jun 26.
Reference Type
BACKGROUND
Sahs AL. Observations on the pathology of saccular aneurysms. J Neurosurg. 1966 Apr;24(4):792-806. doi: 10.3171/jns.1966.24.4.0792. No abstract available.
Reference Type
BACKGROUND
Scanarini M, Mingrino S, Giordano R, Baroni A. Histological and ultrastructural study of intracranial saccular aneurysmal wall. Acta Neurochir (Wien). 1978;43(3-4):171-82. doi: 10.1007/BF01587953.
Reference Type
BACKGROUND
Krex D, Schackert HK, Schackert G. Genesis of cerebral aneurysms--an update. Acta Neurochir (Wien). 2001;143(5):429-48; discussion 448-9. doi: 10.1007/s007010170072.
Reference Type
BACKGROUND
Kataoka K, Taneda M, Asai T, Kinoshita A, Ito M, Kuroda R. Structural fragility and inflammatory response of ruptured cerebral aneurysms. A comparative study between ruptured and unruptured cerebral aneurysms. Stroke. 1999 Jul;30(7):1396-401. doi: 10.1161/01.str.30.7.1396.
Reference Type
BACKGROUND
Chyatte D, Bruno G, Desai S, Todor DR. Inflammation and intracranial aneurysms. Neurosurgery. 1999 Nov;45(5):1137-46; discussion 1146-7. doi: 10.1097/00006123-199911000-00024.
Reference Type
BACKGROUND
Bruno G, Todor R, Lewis I, Chyatte D. Vascular extracellular matrix remodeling in cerebral aneurysms. J Neurosurg. 1998 Sep;89(3):431-40. doi: 10.3171/jns.1998.89.3.0431.
Reference Type
BACKGROUND
Nakajima N, Nagahiro S, Sano T, Satomi J, Satoh K. Phenotypic modulation of smooth muscle cells in human cerebral aneurysmal walls. Acta Neuropathol. 2000 Nov;100(5):475-80. doi: 10.1007/s004010000220.
Reference Type
BACKGROUND
Kosierkiewicz TA, Factor SM, Dickson DW. Immunocytochemical studies of atherosclerotic lesions of cerebral berry aneurysms. J Neuropathol Exp Neurol. 1994 Jul;53(4):399-406. doi: 10.1097/00005072-199407000-00012.
Reference Type
BACKGROUND
Aydin F. Do human intracranial arteries lack vasa vasorum? A comparative immunohistochemical study of intracranial and systemic arteries. Acta Neuropathol. 1998 Jul;96(1):22-8. doi: 10.1007/s004010050856.
Reference Type
BACKGROUND
Ushikoshi S, Kikuchi Y, Houkin K, Miyasaka K, Abe H. Aggravation of brainstem symptoms caused by a large superior cerebellar artery aneurysm after embolization by Guglielmi detachable coils--case report. Neurol Med Chir (Tokyo). 1999 Jul;39(7):524-9. doi: 10.2176/nmc.39.524.
Reference Type
BACKGROUND
Meyers PM, Lavine SD, Fitzsimmons BF, Commichau C, Parra A, Mayer SA, Solomon RA, Connolly ES Jr. Chemical meningitis after cerebral aneurysm treatment using two second-generation aneurysm coils: report of two cases. Neurosurgery. 2004 Nov;55(5):1222. doi: 10.1227/01.neu.0000140987.71791.df.
Reference Type
BACKGROUND
Berenstein A, Song JK, Niimi Y, Namba K, Heran NS, Brisman JL, Nahoum MC, Madrid M, Langer DJ, Kupersmith MJ. Treatment of cerebral aneurysms with hydrogel-coated platinum coils (HydroCoil): early single-center experience. AJNR Am J Neuroradiol. 2006 Oct;27(9):1834-40.
Reference Type
BACKGROUND
Bendszus M, Solymosi L. Cerecyte coils in the treatment of intracranial aneurysms: a preliminary clinical study. AJNR Am J Neuroradiol. 2006 Nov-Dec;27(10):2053-7.
Reference Type
BACKGROUND
Deshaies EM, Adamo MA, Boulos AS. A prospective single-center analysis of the safety and efficacy of the hydrocoil embolization system for the treatment of intracranial aneurysms. J Neurosurg. 2007 Feb;106(2):226-33. doi: 10.3171/jns.2007.106.2.226.
Reference Type
BACKGROUND
Im SH, Han MH, Kwon BJ, Jung C, Kim JE, Han DH. Aseptic meningitis after embolization of cerebral aneurysms using hydrogel-coated coils: report of three cases. AJNR Am J Neuroradiol. 2007 Mar;28(3):511-2.
Reference Type
BACKGROUND
Stracke CP, Krings T, Moller-Hartmann W, Mahdavi A, Klug N. Severe inflammatory reaction of the optic system after endovascular treatment of a supraophthalmic aneurysm with bioactive coils. AJNR Am J Neuroradiol. 2007 Aug;28(7):1401-2. doi: 10.3174/ajnr.A0550.
Reference Type
BACKGROUND
Schmidt GW, Oster SF, Golnik KC, Tumialan LM, Biousse V, Turbin R, Prestigiacomo CJ, Miller NR. Isolated progressive visual loss after coiling of paraclinoid aneurysms. AJNR Am J Neuroradiol. 2007 Nov-Dec;28(10):1882-9. doi: 10.3174/ajnr.A0690.
Reference Type
BACKGROUND
Kang HS, Han MH, Lee TH, Shin YS, Roh HG, Kwon OK, Kwon BJ, Kim SY, Kim SH, Byun HS. Embolization of intracranial aneurysms with hydrogel-coated coils: result of a Korean multicenter trial. Neurosurgery. 2007 Jul;61(1):51-8; discussion 58-9. doi: 10.1227/01.neu.0000279723.67779.f0.
Reference Type
BACKGROUND
Pickett GE, Laitt RD, Herwadkar A, Hughes DG. Visual pathway compromise after hydrocoil treatment of large ophthalmic aneurysms. Neurosurgery. 2007 Oct;61(4):E873-4; discussion E874. doi: 10.1227/01.NEU.0000298918.55119.7C.
Reference Type
BACKGROUND
Horie N, Kitagawa N, Morikawa M, Tsutsumi K, Kaminogo M, Nagata I. Progressive perianeurysmal edema induced after endovascular coil embolization. Report of three cases and review of the literature. J Neurosurg. 2007 May;106(5):916-20. doi: 10.3171/jns.2007.106.5.916.
Reference Type
BACKGROUND
Marchan EM, Sekula RF Jr, Ku A, Williams R, O'Neill BR, Wilberger JE, Quigley MR. Hydrogel coil-related delayed hydrocephalus in patients with unruptured aneurysms. J Neurosurg. 2008 Aug;109(2):186-90. doi: 10.3171/JNS/2008/109/8/0186.
Reference Type
BACKGROUND
Fanning NF, Willinsky RA, ter Brugge KG. Wall enhancement, edema, and hydrocephalus after endovascular coil occlusion of intradural cerebral aneurysms. J Neurosurg. 2008 Jun;108(6):1074-86. doi: 10.3171/JNS/2008/108/6/1074.
Reference Type
BACKGROUND
White JB, Cloft HJ, Kallmes DF. But did you use HydroCoil? Perianeurysmal edema and hydrocephalus with bare platinum coils. AJNR Am J Neuroradiol. 2008 Feb;29(2):299-300. doi: 10.3174/ajnr.A0877. Epub 2007 Nov 16.
Reference Type
BACKGROUND
Marden FA, Putman CM. Perianeurysm edema with second-generation bioactive coils. Surg Neurol. 2008 Jun;69(6):627-32; discussion 632. doi: 10.1016/j.surneu.2007.01.069. Epub 2007 Oct 31.
Reference Type
BACKGROUND
Turner RD, Byrne JV, Kelly ME, Mitsos AP, Gonugunta V, Lalloo S, Rasmussen PA, Fiorella D. Delayed visual deficits and monocular blindness after endovascular treatment of large and giant paraophthalmic aneurysms. Neurosurgery. 2008 Sep;63(3):469-74; discussion 474-5. doi: 10.1227/01.NEU.0000324730.37144.4B.
Reference Type
BACKGROUND
Im SH, Han MH, Kwon OK, Kwon BJ, Kim SH, Kim JE, Oh CW. Endovascular coil embolization of 435 small asymptomatic unruptured intracranial aneurysms: procedural morbidity and patient outcome. AJNR Am J Neuroradiol. 2009 Jan;30(1):79-84. doi: 10.3174/ajnr.A1290. Epub 2008 Sep 3.
Reference Type
BACKGROUND
Killer M, Baltsavias G, Huemer M, Richling B. Visual worsening after incomplete coiling of a small asymptomatic aneurysm: case report and review of the literature. Minim Invasive Neurosurg. 2009 Feb;52(1):39-43. doi: 10.1055/s-0028-1104565. Epub 2009 Feb 26.
Reference Type
BACKGROUND
Nishino K, Ito Y, Hasegawa H, Shimbo J, Kikuchi B, Fujii Y. Development of cranial nerve palsy shortly after endosaccular embolization for asymptomatic cerebral aneurysm: report of two cases and literature review. Acta Neurochir (Wien). 2009 Apr;151(4):379-83. doi: 10.1007/s00701-009-0234-4. Epub 2009 Mar 5.
Reference Type
BACKGROUND
Hara A, Yoshimi N, Mori H. Evidence for apoptosis in human intracranial aneurysms. Neurol Res. 1998 Mar;20(2):127-30. doi: 10.1080/01616412.1998.11740494.
Reference Type
BACKGROUND
Other Identifiers
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20137
Identifier Type: -
Identifier Source: org_study_id
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