Coronary Bifurcation LesionBOVASNCT01300494
BOVAS: Bifurcation Optimal Viewing Angle Selection Study
An observational study of Coronary Bifurcation Lesion, run by University Hospital, Gasthuisberg.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bifurcation Lesion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient older than 18 years of age
- Informed consent available
Who cannot join
- Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
- Impaired renal function (serum creatinine > 2.0 mg/dl)
About this study
Official title: 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.
- Conditions
- Coronary Bifurcation Lesion
- Keywords
- bifurcation lesion, optimal viewing angle, automated software
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300494
- Sponsor's protocol ID
- BOVAS 2 08.02.2011
- Acronym
- BOVAS
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bifurcation Optimal Viewing Angle Selection Study
- ClinicalTrials.gov ID
- NCT01300494
- Acronym / sponsor ID
- BOVAS / BOVAS 2 08.02.2011
- Conditions
- Coronary Bifurcation Lesion
- Keywords
- bifurcation lesion, optimal viewing angle, automated software
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient older than 18 years of age
- Informed consent available
Key exclusion criteria (2 listed)
- Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
- Impaired renal function (serum creatinine > 2.0 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bifurcation Lesion, run by University Hospital, Gasthuisberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.