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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01490463
First Posted: December 13, 2011
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition
Unruptured Intracranial Aneurysms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms: Incidence and Influence on Clinical Outcome in a Prospective Study.

Resource links provided by NLM:


Further study details as provided by Erdem Güresir, Johann Wolfgang Goethe University Hospitals:

Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with unruptured intracranial aneurysm undergoing endovascular or surgical treatment
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490463


Locations
Germany
Department of Neurosurgery, Goethe-University
Frankfurt am Main, Hessen, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Department of Neurosurgery, Goethe-University Frankfurt am Main
Institute of Neuroradiology, Goethe-University Frankfurt am Main
  More Information

Additional Information:
Responsible Party: Erdem Güresir, Department of Neurosurgery, Goethe-University Frankfurt am Main, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01490463     History of Changes
Other Study ID Numbers: JohannWGUH_LESUIA
First Submitted: December 12, 2011
First Posted: December 13, 2011
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by Erdem Güresir, Johann Wolfgang Goethe University Hospitals:
Treatment of

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases