Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms (LESUIA)

This study has been completed.

Sponsor:

Collaborators:

Department of Neurosurgery, Goethe-University Frankfurt am Main

Institute of Neuroradiology, Goethe-University Frankfurt am Main

Information provided by (Responsible Party):

Erdem Güresir, Johann Wolfgang Goethe University Hospitals

ClinicalTrials.gov Identifier:

NCT01490463

First received: December 12, 2011

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 12, 2011
Last Updated Date	January 28, 2013
Start Date ^ICMJE	August 2011
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01490463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms
Official Title ^ICMJE	Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms: Incidence and Influence on Clinical Outcome in a Prospective Study.
Brief Summary	The purpose of this study is to determine the incidence and impact of brain lesions in MRI after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological outcome of patients.
Detailed Description	Silent ischemic lesions after treatment of unruptured intracranial aneurysm (UIA) might alter patients' clinical and neurological outcome. Furthermore silent brain lesions are not well documented after endovascular and surgical treatment of unruptured intracranial aneurysms. Therefore, the investigators investigate the incidence and influence of treatment-related ischemic lesions in magnetic resonance / diffusion-weighted-imaging after endovascular and surgical treatment of UIA.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with unruptured intracranial aneurysm undergoing endovascular or surgical treatment
Condition ^ICMJE	Unruptured Intracranial Aneurysms
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	January 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: diagnosis and treatment of unruptured intracranial aneurysm age ≥ 18 yrs written informed consent by patients prior to study participation willingness to participate in follow-up Exclusion Criteria: ruptured intracranial aneurysm contraindication for MRI Participation in an intervention-/AMG-study
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01490463
Other Study ID Numbers ^ICMJE	JohannWGUH_LESUIA
Has Data Monitoring Committee	Not Provided
Responsible Party	Erdem Güresir, Johann Wolfgang Goethe University Hospitals
Study Sponsor ^ICMJE	Johann Wolfgang Goethe University Hospitals
Collaborators ^ICMJE	Department of Neurosurgery, Goethe-University Frankfurt am Main Institute of Neuroradiology, Goethe-University Frankfurt am Main
Investigators ^ICMJE	Not Provided
Information Provided By	Johann Wolfgang Goethe University Hospitals
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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