BOVAS: Bifurcation Optimal Viewing Angle Selection Study

Coronary Bifurcation Lesion Clinical Trial

— BOVAS  

Official title:

Bifurcation Optimal Viewing Angle Selection Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01300494
• Other study ID #: BOVAS 2 08.02.2011
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2011
• Last updated: February 18, 2011
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2011
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Bifurcation Lesion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg	Katholieke Universiteit Leuven