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Giant Intracranial Aneurysm Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Dr. med. Julius Dengler, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02066493
First received: February 17, 2014
Last updated: February 18, 2014
Last verified: February 2014
  Purpose
The purpose of this study is to generate detailed insight into which therapies of giant intracranial aneurysms are being conducted, to document the natural history and the outcome of treatment over 5 years after inclusion into the Registry and to follow imaging data of giant aneurysms over years after diagnosis.

Condition
Intracranial Aneurysms

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Giant Intracranial Aneurysm Registry

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • aneurysm rupture rate - diagnosed radiologically (e.g. by CT) or clinically [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • health status of the patient quantified by modified Rankin Scale in combination with a basic neurological exam [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: December 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • diagnosis of a giant intracranial aneurysm

Exclusion Criteria:

  • age younger than 18
  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: NCT02066493

Locations
Germany
Department of Neurology - Charité Berlin
Berlin, Germany
Department of Neurosurgery, Charité Berlin
Berlin, Germany
Department of Neurosurgery and Neuroradiology, Klinikum Deggendorf
Deggendorf, Germany
Department of Neurosurgery, University of Freiburg
Freiburg, Germany
Department of Neurosurgery - University of Goettingen
Goettingen, Germany
Department of Neurosurgery - University of Greifswald
Greifswald, Germany
Department of Neurosurgery - University of Hamburg
Hamburg, Germany
Department of Neurosurgery - Technical University of Munich
Munich, Germany
Department of Neurosurgery - University of Regensburg
Regensburg, Germany
Institut für Klinische Epidemiologie und Biometrie der Universität Wuerzburg
Wuerzburg, Germany
Japan
Department of Neurosurgery, Jikei University
Tokio, Japan
Switzerland
Department of Neurosurgery - University of Geneva
Geneva, Switzerland
Department of Neuroradiology - Klinikum Hirslanden
Zurich, Switzerland
Sponsors and Collaborators
Dr. med. Julius Dengler
Charite University, Berlin, Germany
Investigators
Study Chair: Julius Dengler, MD Charite University, Berlin, Germany
Study Director: Peter Vajkoczy, Prof., MD Charite University, Berlin, Germany
Study Director: Veit Rohde, Prof., MD University of Goettingen
Study Director: Peter Heuschmann, Prof., MD University of Wuerzburg
Study Director: Bernhard Meyer, Prof., MD Technische Universität München
Study Director: Daniel Ruefenacht, Prof., MD Klinikum Hirslanden Zurich
Study Director: Matthias Endres, Prof., MD Charite University, Berlin, Germany
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Julius Dengler, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02066493     History of Changes
Other Study ID Numbers: Giant  CS-2009-13 
Study First Received: February 17, 2014
Last Updated: February 18, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
giant intracranial aneurysm, cerebrovascular bypass, flow diverter

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

ClinicalTrials.gov processed this record on January 14, 2017