An observational study in Cardiac Ischemia, Coronary Artery Disease and Coronary Stenosis, sponsored by Volcano Corporation. Completed at 40 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Volcano Corporation (part of Philips) · Observational
The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.
This study is intended to demonstrate the diagnostic performance of the image-derived physiology model using the invasive physiological measures as the reference standard.
Specific objectives include the following:
i) Demonstrate the sensitivity and specificity of image-derived iFR and FFR results for identifying functionally significant lesions as determined by the corresponding invasive measures; ii) Demonstrate the diagnostic agreement of image-derived iFR and FFR estimates with the corresponding invasive measures; iii) Demonstrate the diagnostic performance of image derived physiology estimate (iFR/FFR) is superior to visual angiographic assessment for the identification of functionally significant stenoses as determined by the corresponding invasive physiology measures; iv) Demonstrate reproducibility of the image-derived estimate for a given operator and across multiple operators for a given lesion.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 441 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Volcano Corporation is the lead sponsor of 14 studies on the registry; none are open to participants now.
First submitted after Volcano Corporation became part of Philips.
Counted across the registry records on this site, refreshed daily.
Patients referred for cardiac catheterization for diagnostic and/or treatment purposes will undergo a screening angiogram to assess eligibility. Eligible patients will be those with at least one major epicardial vessel having a lesion of 40-90% diameter stenosis per visual assessment of angiogram.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients referred for cardiac catheterization for diagnostic and/or treatment purposes will undergo a screening angiogram to assess eligibility. Eligible patients will be those with at least one major epicardial vessel having a lesion of 40-90% diameter stenosis per visual assessment of angiogram.
Diagnostic Test: iFR
Patients will undergo standard of care diagnostic coronary angiography using established invasive physiological criteria for iFR and FFR to aid in clinical decision making for coronary revascularization. Angiograms will be made in at least two projections, and the treating physician will record his/her estimation of stenosis severity. Resting iFR and Pd/Pa measures will then be made distal to the target lesion; adenosine will be administered, and the FFR measures will be made without moving the wire. An iFR pullback will then be made after hyperemia as abated. Patients will be treated or deferred from treatment based on physician decision aided by the iFR measures.
Diagnostic accuracy of the image-derived iFR
Diagnostic accuracy of the image-derived iFR and FFR estimate for a given lesion compared to the corresponding invasive iFR and FFR values.
Time frame: 1 day
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.