BOVAS: Bifurcation Optimal Viewing Angle Selection Study (BOVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01300494
Recruitment Status : Unknown
Verified February 2011 by University Hospital, Gasthuisberg.
Recruitment status was:  Not yet recruiting
First Posted : February 21, 2011
Last Update Posted : February 21, 2011
Katholieke Universiteit Leuven
Information provided by:
University Hospital, Gasthuisberg

Brief Summary:
An optimal angiographic viewing angle is critical for correct diagnosis and intervention in coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study aims at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will improve the selection of the best viewing angle.

Condition or disease
Coronary Bifurcation Lesion

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bifurcation Optimal Viewing Angle Selection Study
Study Start Date : March 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : June 2012

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In patients undergoing coronary angiography, those with an angiographically significant bifurcation lesion will be identified. A total of 50 patients will be selected. After diagnostic angiography, optimal viewing angles for the bifurcation lesion will be calculated using the dedicated Medis (Leiden, the Netherlands) software.

Inclusion Criteria:

  • Patient older than 18 years of age
  • Informed consent available

Exclusion Criteria:

  • Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
  • Impaired renal function (serum creatinine > 2.0 mg/dl)

Responsible Party: dr. Tom Adriaenssens, University Hospitals Leuven Identifier: NCT01300494     History of Changes
Other Study ID Numbers: BOVAS 2 08.02.2011
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by University Hospital, Gasthuisberg:
bifurcation lesion
optimal viewing angle
automated software