PR93529

The innovative software "CAAS vFFR" by Pie Medical Imaging for the non-invasive physiological assessment of intermediate coronary lesions is the subject of FAST III, a multicenter European clinical trial which will investigate the effectiveness of the vessel Fractional Flow Reserve (vFFR) guided revascularization as compared to conventional FFR guided revascularization

MAASTRICHT, Netherlands, December 12, 2021 /PRNewswire=KYODO JBN/--

Pie Medical Imaging ("PMI"), a global leader in cardiac imaging, part of the

Esaote Group, today announced the beginning of FASTIII, a multicenter

randomized clinical trial which will investigate the use of angiography-based

vessel fractional flow reserve (CAAS vFFR) in patients undergoing coronary

revascularization procedures.

The FASTIII trial, that is led by Dr. Joost Daemen (cardiologist at the

Thoraxcenter at the Erasmus University Medical Center, Rotterdam, The

Netherlands), is an investigator initiated international, multi-center

randomized, non-inferiority trial aiming to enroll a total of 2228 patients, in

7 European countries and 35 hospitals and is sponsored by the European

Cardiovascular Research Institute (ECRI).

The FAST III study aims to demonstrate non-inferiority of CAAS vFFR guided

revascularization as compared to a conventional invasive wire based FFR guided

revascularization in patients with either stable coronary syndrome or non-ST

segment elevation myocardial infarction and intermediate coronary artery

lesions.

vFFR can assess whether a coronary artery narrowing is functionally severe and

requires treatment. CAAS vFFR allows doing so without the need of invasive

wires- that are part of the routine practice to measure pressure gradients

(FFR) – and adenosine.

The high diagnostic accuracy of CAAS vFFR, which calculates pressure drop and

vFFR value using angiography images only was recently confirmed by the results

of FAST I, FAST Extend and FASTII studies which validated vFFR as an accurate

and easy to use tool to assess coronary physiology.

"We are confident that this new study will lead to a broader use of methods

based on angiographic images for a safe and accurate assessment of severity and

percentage of artery stenosis" said René Guillaume, PMI Managing Director.

The trial is funded by research grants from Pie Medical Imaging (Maastricht,

the Netherlands) and Siemens Healthineers GmbH (Erlangen, Germany).

About Pie Medical Imaging

Pie Medical Imaging BV is a world leader in analysis and visualization of

cardiovascular images in Maastricht (The Netherlands), it hosts the global

sales for the CAAS and 3mensio product lines. PMI and 3mensio Medical Imaging

are part of the Esaote Group, leader in the biomedical equipment sector. More

information about PMI is available at www.piemedicalimaging.com

Photo -

https://mma.prnewswire.com/media/1704306/CAAS_vFFR_real_time_cathlab.jpg

Logo - https://mma.prnewswire.com/media/1511581/PMI__Logo.jpg

SOURCE: Pie Medical Imaging