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BOVAS: Bifurcation Optimal Viewing Angle Selection Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University Hospital, Gasthuisberg.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01300494
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: dr. Tom Adriaenssens, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT01300494     History of Changes
Other Study ID Numbers: BOVAS 2 08.02.2011
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013