Open Bifurcation Surgery Study (OBI)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Vascutek Ltd.

Information provided by (Responsible Party):

Alexander Hyhlik-Duerr, M. D., University of Heidelberg

ClinicalTrials.gov Identifier:

NCT01649908

First received: July 20, 2012

Last updated: August 6, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 20, 2012
Last Updated Date	August 6, 2012
Start Date ^ICMJE	July 2012
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: July 24, 2012)	cardiac function with echocardiography [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01649908 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	Open Bifurcation Surgery Study
Official Title ^ICMJE	Evaluation of Cardiac Function in Different Techniques in Infrarenal Aortic Surgery
Brief Summary	Different cross clamping techniques in aortic surgery causes different cardiac stress
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients with infrarenal aortic aneurysms
Condition ^ICMJE	Infrarenal Aortic Aneurysm
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	sectional cross clamping simultaniously cross clamping EVAR
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	Active, not recruiting
Enrollment ^ICMJE	60
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: AAA > 5cm Exclusion Criteria: emergency cases
Gender	Male
Ages	18 Years and older
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	NCT01649908
Other Study ID Numbers ^ICMJE	501961
Has Data Monitoring Committee	No
Responsible Party	Alexander Hyhlik-Duerr, M. D., University of Heidelberg
Study Sponsor ^ICMJE	Alexander Hyhlik-Duerr, M. D.
Collaborators ^ICMJE	Vascutek Ltd.
Investigators ^ICMJE	Not Provided
Information Provided By	University of Heidelberg
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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