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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
  Purpose

Different cross clamping techniques in aortic surgery causes different cardiac stress


Condition
Infrarenal Aortic Aneurysm

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Cardiac Function in Different Techniques in Infrarenal Aortic Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • cardiac function with echocardiography [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2012
Groups/Cohorts
sectional cross clamping
simultaniously cross clamping
EVAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with infrarenal aortic aneurysms

Criteria

Inclusion Criteria:

  • AAA > 5cm

Exclusion Criteria:

  • emergency cases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649908

Locations
Germany
University of Heidelberg
Heidelberg, Germany
Sponsors and Collaborators
Alexander Hyhlik-Duerr, M. D.
Vascutek Ltd.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alexander Hyhlik-Duerr, M. D., M.D., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01649908     History of Changes
Other Study ID Numbers: 501961
Study First Received: July 20, 2012
Last Updated: August 6, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on June 17, 2013