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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
  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 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490463

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

Additional Information:
No publications provided

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
Study First Received: December 12, 2011
Last Updated: January 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Treatment of

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

ClinicalTrials.gov processed this record on November 25, 2014