We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

BOVAS: Bifurcation Optimal Viewing Angle Selection Study (BOVAS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by University Hospital, Gasthuisberg.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300494
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
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.
Collaborator:
Katholieke Universiteit Leuven
Information provided by:
University Hospital, Gasthuisberg
  Purpose
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
Coronary Bifurcation Lesion

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bifurcation Optimal Viewing Angle Selection Study

Further study details as provided by University Hospital, Gasthuisberg:

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: February 18, 2011
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
Last Verified: February 2011

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