Giant Intracranial Aneurysm Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Charite University, Berlin, Germany
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Julius Dengler, MD ++49-30-450 560 002 julius.dengler@charite.de
Contact: Peter Vajkoczy, Prof., MD ++49-30-450 560 002 peter.vajkoczy@charite.de

Locations
Germany
Department of Neurology - Charité Berlin Active, not recruiting
Berlin, Germany
Department of Neurosurgery, Charité Berlin Recruiting
Berlin, Germany
Contact: Julius Dengler, MD    ++49-30-450 560 002    julius.dengler@charite.de   
Department of Neurosurgery and Neuroradiology, Klinikum Deggendorf Recruiting
Deggendorf, Germany
Contact: Adisa Kursumovic, MD       Adisa.Kursumovic@donau-isar-klinikum.de   
Principal Investigator: Adisa Kursumovic, MD         
Department of Neurosurgery, University of Freiburg Recruiting
Freiburg, Germany
Contact: Sven Glaesker, Professor, MD       sven.glaesker@uniklinik-freiburg.de   
Principal Investigator: Sven Glaesker, Professor, MD         
Department of Neurosurgery - University of Goettingen Recruiting
Goettingen, Germany
Contact: Dorothee Mielke, MD       doromielke@hotmail.com   
Principal Investigator: Dorothee Mielke, MD         
Department of Neurosurgery - University of Greifswald Recruiting
Greifswald, Germany
Contact: Susanne Guhl, MD       susanne.guhl@uni-greifswald.de   
Principal Investigator: Susanne Guhl, MD         
Department of Neurosurgery - University of Hamburg Recruiting
Hamburg, Germany
Contact: Nils O Schmidt, MD       nschmidt@uke.uni-hamburg.de   
Principal Investigator: Nils O Schmidt, MD         
Department of Neurosurgery - Technical University of Munich Recruiting
Munich, Germany
Contact: Maria Wostrack, MD       maria.wostrack@lrz.tum.de   
Principal Investigator: Maria Wostrack, MD         
Department of Neurosurgery - University of Regensburg Recruiting
Regensburg, Germany
Contact: Karl M Schebesch, MD       Karl-Michael.Schebesch@klinik.uni-regensburg.de   
Principal Investigator: Karl M Schebesch, MD         
Institut für Klinische Epidemiologie und Biometrie der Universität Wuerzburg Active, not recruiting
Wuerzburg, Germany
Japan
Department of Neurosurgery, Jikei University Recruiting
Tokio, Japan
Contact: Naoki Kato, MD       nao-kth@jikei.ac.jp   
Principal Investigator: Naoki Kato, MD         
Switzerland
Department of Neurosurgery - University of Geneva Recruiting
Geneva, Switzerland
Contact: Philippe Bijlenga, PhD, MD       Philippe.Bijlenga@hcuge.ch   
Principal Investigator: Philippe Bijlenga, PhD, MD         
Department of Neuroradiology - Klinikum Hirslanden Active, not recruiting
Zurich, Switzerland
Sponsors and Collaborators
Dr. med. Julius Dengler
Charite University, Berlin, Germany
Investigators
Study Chair: Julius Dengler, MD Charité Berlin
Study Director: Peter Vajkoczy, Prof., MD Charité Berlin
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 Charité Berlin
  More Information

Additional Information:
Publications:
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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014