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BOVAS: Bifurcation Optimal Viewing Angle Selection Study (BOVAS)

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
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




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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.
Criteria

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
ClinicalTrials.gov 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