LIPSIA-STRATEGY trial demonstrates non-inferiority of CAAS vFFR guided revascularization against pressure wire-based FFR revascularization

• LIPSIA-STRATEGY evaluated whether revascularization guided by angiography-based FFR using CAAS vFFR (vessel Fractional Flow Reserve), delivers clinical outcomes comparable to guidance by pressure wire-based FFR.
• Conclusive trial results provide further randomized clinical evidence validating CAAS vFFR as a safe and effective alternative for wire-based physiology-guided revascularization.
• Results independently confirm the findings of FAST III, demonstrating comparable clinical outcomes while enabling a faster, less invasive workflow with lower radiation exposure, ultimately benefiting both caregivers and patients.

MAASTRICHT, Netherlands, Nov. 3, 2026 /PRNewswire/ -- Pie Medical Imaging, a global leader in cardiovascular image analysis solutions, announces the results of the LIPSIA-STRATEGY trial, presented during the Late-Breaking Clinical Trials session at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 congress and simultaneously published in the Journal of the American College of Cardiology (JACC). The trial demonstrated non-inferiority of revascularization guided by angiography-derived CAAS vFFR compared with revascularization guided by conventional pressure wire-based FFR. 

LIPSIA-STRATEGY is an investigator-initiated, multicenter, randomized clinical trial involving 1,053 patients with intermediate coronary artery stenoses. The study was designed to evaluate whether coronary revascularization guided by angiography-derived CAAS vFFR could deliver clinical outcomes comparable to those achieved with conventional pressure wire-based FFR. Patients were randomized to either a vFFR-guided or FFR-guided treatment strategy, with 1-year major adverse cardiovascular events (MACE) serving as the primary endpoint. 

Under the leadership of Prof. Dr. med. Holger Thiele, Heart Center Leipzig at Leipzig University, together with the investigators and participating study centers, the trial successfully met its primary endpoint, demonstrating non-inferior clinical outcomes for the CAAS vFFR-guided treatment strategy. 

"Angiography-based FFR measurement is easier than wire-based FFR with similar clinical outcome. Thus, this should become the new standard for intermediate coronary artery stenoses." Said Prof. Dr. med. Holger Thiele. 

Bas Kuppens, CEO of Pie Medical Imaging, added "LIPSIA-STRATEGY reinforces the findings of FAST III, adding to the clinical evidence for CAAS vFFR and further strengthening confidence in our angiography-based physiology solution. Together with a less invasive workflow, shorter procedure time and shorter fluoroscopy time, these results bring us another step closer to making physiology-guided decision-making more accessible across the PCI pathway, from diagnostic assessment and treatment planning to post-procedural evaluation. "

About Pie Medical Imaging

Pie Medical Imaging is a global leader in advanced cardiovascular image analysis, quantification and visualization. Based in Maastricht, The Netherlands, the company oversees worldwide innovation and commercialization of the CAAS and 3mensio product lines. With decades of expertise and deep commitment to innovation, Pie Medical Imaging delivers software solutions that empower clinicians, researchers, and industry partners to enhance diagnosis, procedure planning, and image‑guided interventions.

The company complies with international quality and regulatory standards, ensuring high reliability and clinical confidence.

Pie Medical Imaging is part of the Esaote Group, a leader in the biomedical equipment sector.

More information about Pie Medical Imaging is available at www.piemedicalimaging.com.