Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.
During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment.
Fractional Flow Reserve (FFR) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. The instantaneous wave-free ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. Large randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of outcome.
Quantitative Flow Ratio (QFR) is another new method for evaluating the functional significance of coronary stenosis It is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. The diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is enrolling for confirmation.
A stepwise approach of QFR and iFR could make the functional assessment of intermediate stenoses more practical and cost-effective. However before being used as a combination in daily practice, QFR has to be validated in respect to iFR.
The primary objective of the trial is to investigate the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR-iFR-QFR group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QFR and iFR | Diagnostic Test | iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of QFR in comparison to iFR | reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR | 1 hour |
| QFR- iFR diagnostic grey zone calculation. | QFR limits for achieving 95% sensitivity and specificity in comparison to iFR | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of QFR in comparison to FFR | reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to FFR | 1 hour |
| QFR- FFR diagnostic grey zone calculation. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost analysis | Cost savings of removing the need for Adenosine by using iFR. Evaluation of costs by excess/reduced need for stenting when iFR and FFR disagree | 1 hour |
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Patients that undergo angiography because of symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing or abnormal noninvasive testing) and in whom hemodynamic evaluation of an intermediate stenosis is indicated should be screened and considered for participation in the trial
The trial design is set up to be representative for the patient population that under current guidelines should be evaluated with FFR. Therefore the exclusion criteria are limited to the contraindications for adenosine and previous CABG which would not allow accurate evaluation by FFR and QFR respectively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Jensen, MD, PHD | Contact | 0049-201-897-86222 | c.jensen@contilia.de | |
| Pieter Ghijselinck, MD | Contact | 0049-201-897-86273 | p.ghijselinck@contilia.de |
| Name | Affiliation | Role |
|---|---|---|
| Christoph j Jensen, MD | contilia heart and vascular center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contilia heart and vascular center | Recruiting | Essen | North Rhine-Westphalia | 45138 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
QFR limits for achieving 95% sensitivity and specificity in comparison to FFR
| 1 hour |
| Diagnostic performance of iFR in comparison to FFR | reported as sensitivity, specificity, positive and negative likelihood ratio of iFR according to FFR | 1 hour |
| iFR- FFR diagnostic grey zone calculation. | iFR limits for achieving 95% sensitivity and specificity in comparison to FFR | 1 hour |
| effect of 3D QCA characteristics on QFR-iFR-FFR disagreement. | Influence of minimum luminal area (MLA), percentage area stenosis, lesion length, and minimum luminal diameter (MLD) and percentage diameter stenosis in the prediction of QFR-iFR-FFR disagreement. | 1 hour |
| Effect of lesion location on QFR-iFR-FFR disagreement. | Evaluation of lesion location in the prediction of QFR-iFR-FFR disagreement. | 1 hour |
| Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement. | Evaluation of p20-DAC2 score in proximal and mid-LAD stenosis in in the prediction of QFR-iFR-FFR disagreement. | 1 hour |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |