Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02811796 |
Other study ID # |
190678 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 2016 |
Est. completion date |
April 2021 |
Study information
Verified date |
April 2021 |
Source |
University Hospital of Ferrara |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The investigators will collect prospectively baseline, procedural and follow-up data of all
patients receiving successful percutaneous coronary intervention (PCI) and stent
implantation. Angio-based flow fractional reserve (quantitative flow ratio, QFR, Medis
medical imaging systems Leiden, The Netherlands) will be estimated in all patients.
Especially, the investigators at the end of the procedure (this is defined according
operator's judgement) will record 2 orthogonal angiograms (as suggested by QFR instructions)
at 15 frames/second and the same 2 orthogonal angiograms at 30 frames/second. An independent
corelab (blinded to procedural data and clinical outcome) will estimate QFR value (one with
the angiograms at 15 frames and one with those at 30 frames
Description:
Fractional flow reserve (FFR) allows to evaluate the functional significance of coronary
artery lesions, through the ratio of the mean coronary artery pressure after the stenosis to
the mean aortic pressure during maximum hyperaemia. The actual widely accepted cutoff value
is 0.80. Below this value, an intermediate coronary lesion is considered significant and its
treatment with percutaneous coronary intervention (PCI) is justified.
The measurement FFR after stent implantation has a strong predictive value with respect to
death, myocardial infarction, or need for repeat revascularization of the target vessel
within 6 months. The higher the FFR, the lower the event rate. FFR cut-off of 0.90 might be a
useful indicator in daily practice for optimal physiologic stent implantation. Nevertheless,
the use of the FFR in the post stenting , is relatively low, because of costs of the pressure
wire and the adverse effects related to the use of adenosine.
A new method (QFR by Medis medical imaging) for evaluation of the functional significance of
coronary stenosis is based on computer calculation of the FFR value. This calculation is
performed by analysing the coronary angiogram and thus reduces or potentially eliminates the
need for measuring FFR by pressure wires. The QFR method combines a 3D reconstructions of the
target vessel based on two angiographic projections and the contrast flow velocity to compute
the "FFR value". To perform QFR the investigators will acquire two angiographic projections
with angle >25 degree that allow the 3D reconstruction of the vessel (see values below).
Projections for left main (LM) and proximal left anterior descending (LAD) or proximal left
circumflex (LCX): right anterior oblique (RAO) 20, Caudal 45 and anterior-posterior (AP),
Caudal 10
Projections for LAD/diagonal: AP, Cranial 45 and RAO 35, Cranial 20
Projections for LCX/obtuse marginal (OM): left anterior oblique (LAO) 10, Caudal 45 and RAO
25, Caudal 25
Projections for Proximal+Mid right coronary artery (RCA): LAO 45, caudal (CAUD) 0 and AP,
CAUD 0
Projections for postero-lateral artery and posterior-descending artery (PLA/PDA): LAO 45,
CAUD 0 and LAO 30, CAUD 30
Finally, the investigators will assess the relationship between QFR value and adverse events.
We will assess the best QFR value able to discriminate the cumulative occurrence of adverse
events. In the study, we will include also ST-segment elevation myocardial infarction
patients. This subset of patients will be analysed as independent cohort to obtain
preliminary results and will be analysed in a independent study