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The LIPSIA-STRATEGY trial by Pie Medical confirms the non-inferiority of CAAS vFFR-guided revascularization versus FFR-guided revascularization using a pressure wire.
The LIPSIA-STRATEGY study analyzed whether angiography-based FFR-guided revascularization (fractional flow reserve) with the CAAS vFFR system offers clinical results comparable to those obtained with pressure wire-guided FFR.
The solid results of the trial provide new randomized clinical evidence supporting the CAAS vFFR system as a safe and effective alternative to revascularization guided by physiological parameters using a pressure wire.
These findings independently corroborate the conclusions of the FAST III study, showing similar clinical results and, at the same time, enabling a more agile and less invasive workflow, with lower radiation exposure, benefiting both healthcare professionals and patients.
MAASTRICHT, Netherlands, November 3, 2026 /PRNewswire/ -- Pie Medical Imaging, a global leader in cardiovascular image analysis solutions, reports the results of the LIPSIA-STRATEGY trial, presented during the late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 congress and published at the same time in the Journal of the American College of Cardiology (JACC). The trial showed the non-inferiority of angiography-based CAAS vFFR-guided revascularization versus conventional FFR-guided revascularization using a pressure wire.
LIPSIA-STRATEGY is a multicenter, randomized clinical trial initiated by investigators, in which 1,053 patients with intermediate-grade coronary stenoses were included. The study was designed to determine whether coronary revascularization guided by vFFR (angiography-based through the CAAS system) could provide clinical results comparable to those of conventional FFR performed with a pressure wire. The participants were randomly assigned to a treatment strategy guided by vFFR or by FFR, with the incidence of major adverse cardiovascular events (MACE, by its acronym in English) at one year of follow-up defined as the primary endpoint.
Under the direction of professor and doctor of medicine Holger Thiele, from the Leipzig Heart Center (Heart Center Leipzig) of the University of Leipzig, and with the collaboration of the researchers and centers involved, the trial achieved its primary objective, demonstrating non-inferior clinical results for the CAAS vFFR-guided treatment strategy.
"The angiography-based FFR measurement is easier than wire-based FFR with similar clinical results. Therefore, this should become the new standard for intermediate coronary artery stenoses," explained professor and doctor of medicine Holger Thiele.
Bas Kuppens, CEO of Pie Medical Imaging, added: "LIPSIA-STRATEGY reinforces the findings of FAST III, expanding the clinical evidence in favor of CAAS vFFR and further consolidating confidence in our angiography-based physiology solution. Along with a less invasive workflow, a shorter procedure duration, and a reduced fluoroscopy time, these results bring us one step closer to making physiology-guided decision-making more accessible throughout the entire percutaneous coronary intervention (PCI) process, from diagnostic assessment and treatment planning to post-procedure evaluation".
About Pie Medical Imaging
Pie Medical Imaging is a global reference in the analysis, quantification, and visualization of advanced cardiovascular images. Based in Maastricht (Netherlands), the company drives innovation and the international commercialization of the CAAS and 3mensio product lines. Thanks to decades of experience and a constant commitment to innovation, Pie Medical Imaging develops software solutions that help doctors, researchers, and industry partners optimize diagnosis, procedure planning, and image-guided interventions.
The company complies with international quality standards and regulatory requirements, ensuring high reliability and clinical trust.
Pie Medical Imaging is part of the Esaote Group, a leader in the field of biomedical equipment.
You can find more information about Pie Medical Imaging at: www.piemedicalimaging.com.
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