Aneurysm Wall Histology Registry

NCT01444664 | Completed Phase 4

• 1 other identifier: 20137
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Brain Aneurysm

Outcome Measures

Primary Outcomes (1)

• Histological Change

  To determine the relative and absolute differences in histological changes as seen in the tissue samples comparing this to the CSF and blood plasma samples. To also determine if there is any gene expressions that can be utilized as predictive markers in this cohort of patients.

  an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur

Secondary Outcomes (3)

• Treatment related morbidity and mortality

  up to approximately 1 year post treatment

• Clinical Outcome

  approximately clinical outcome at 6 months after surgical clipping at routine follow up visit and approximately 12 months after clipping at routine follow up visit if indicated

• Bleeding Rate

  post treatment during approximate follow up periods 6mo and 12mo clinical follow up

Study Arms (1)

Aneurysm

EXPERIMENTAL

Procedure: Surgical Clipping of Aneurysm

Interventions

Surgical Clipping of Aneurysm PROCEDURE

Surgical clipping of intracranial aneurysm

Aneurysm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Albany Medical College: collaborator
• Northwestern University: collaborator
• Stony Brook University: collaborator
• Royal University Hospital Foundation: collaborator
• Indiana University: collaborator
• Providence Health & Services: collaborator
• University of Illinois at Chicago: collaborator
• Vanderbilt University: collaborator
• Methodist Health System: collaborator

Study Sites (10)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University Of Illinois

Chicago, Illinois, 60612, United States

Location

Goodman Campbell

Indianapolis, Indiana, 46202, United States

Location

Albany Medical Center

Albany, New York, 12208-3412, United States

Location

SUNY - Stonybrook University Medical Center

Stony Brook, New York, 11794, United States

Location

Providence Health

Portland, Oregon, 97225, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

Methodist Healthcare - Memphis

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

Royal University Hospital

Saskatoon, Ontario, S7N OW8, Canada

Location

Related Publications (35)

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• 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.

  PMID: 9678510 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.

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• 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.

  PMID: 15791738 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Henry Woo

  SUNY - Stonybrook

  PRINCIPAL INVESTIGATOR

• Arthur Adam, MD

  Baptist Hospital

  PRINCIPAL INVESTIGATOR

• Mike Kelly

  Royal University Hospital Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: October 3, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 24, 2016

Record last verified: 2015-04

Locations

US (9); CA (1)