- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300494
BOVAS: Bifurcation Optimal Viewing Angle Selection Study (BOVAS)
February 18, 2011 updated by: University Hospital, Gasthuisberg
Bifurcation Optimal Viewing Angle Selection Study
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
February 18, 2011
First Submitted That Met QC Criteria
February 18, 2011
First Posted (Estimate)
February 21, 2011
Study Record Updates
Last Update Posted (Estimate)
February 21, 2011
Last Update Submitted That Met QC Criteria
February 18, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- BOVAS 2 08.02.2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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