MAASTRICHT, Netherlands,
June 18, 2024 /PRNewswire/
-- Pie Medical Imaging, a global leader in cardiac
imaging, announced the completion of enrollment in FASTIII,
a multi-center randomized clinical trial, which investigates the
use of angiography-based vessel fractional flow reserve (CAAS
vFFR) in patients undergoing coronary revascularization
procedures. vFFR can assess whether a coronary artery
narrowing is functionally significant and may require
revascularization.
FASTIII is the largest non-inferiority trial running
(having enrolled 2228 patients), in which an angiographically
derived vFFR guided strategy is compared to a FFR guided
strategy to guide coronary revascularization. The primary
endpoint is a composite of all-cause death, any myocardial
infarction, or any revascularization at 1-year post
randomization.
Following the tremendous efforts of the principal investigator,
Dr Joost Daemen (cardiologist
at Thoraxcenter at the Erasmus
University Medical Center, Rotterdam, The Netherlands), over 35
participating centers and ECRI (sponsor of the trial), the patient
enrollment has concluded.
"The FASTIII trial is aimed to establish the role of vFFR
to coronary revascularization in patients with intermediate
coronary artery lesions. An important milestone was
reached Friday, May 31st,
2024, when the last patient was enrolled", said Joost Daemen Principal Investigator of the
trial. "The next phase will consist of close follow-up of all
patients who generously agreed to participate in the important
trial. We hope to present our findings by the end of
2025".
Additionally,
"PMI is committed to providing clinicians and patients with
long-term coronary data to inform their treatment decisions, " said
René Guillaume, Managing Director at Pie Medical Imaging.
"Our prior studies have shown diagnostic accuracy and
reproducibility of vFFR calculation". FASTIII will establish
its role in routine clinical practice.
The trial is funded by research grants from Pie Medical
Imaging (Maastricht, The
Netherlands) and Siemens Healthineers (Erlangen,
Germany). The study is
sponsored by ECRI (European Cardiovascular Research
Institute, Rotterdam-the
Netherlands). Cardialysis (Rotterdam, The Netherlands) is responsible for
trial services including trial management and Core Laboratory
activities.
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 part of the Esaote
Group, leader in the biomedical equipment sector. More
information about PMI is available at
www.piemedicalimaging.com
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