LIPSIA-STRATEGY Trial Backs Angiography-Derived CAAS vFFR as Wire-Free Alternative for Coronary Revascularization

Pie Medical Imaging has announced results from the LIPSIA-STRATEGY trial, a randomized clinical study that tested whether revascularization guided by angiography-derived CAAS vFFR (vessel Fractional Flow Reserve) delivers clinical outcomes comparable to conventional pressure wire-based FFR. The findings were 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).

Trial Design and Primary Endpoint

LIPSIA-STRATEGY is an investigator-initiated, multicenter, randomized clinical trial involving 1,053 patients with intermediate coronary artery stenoses. The study was built to determine whether coronary revascularization guided by angiography-derived CAAS vFFR could match the clinical outcomes achieved with conventional pressure wire-based FFR.

Patients were randomized to either a vFFR-guided or an FFR-guided treatment strategy. The primary endpoint was 1-year major adverse cardiovascular events (MACE).

Leadership and Result

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

What Non-Inferiority Means for Clinical Practice

Non-inferiority is a specific statistical claim: it indicates that the angiography-derived approach performed no worse than the established pressure wire method within the trial's predefined margin, rather than claiming superiority. For clinicians, the practical significance lies in workflow. Pressure wire-based FFR requires passing a sensor-tipped wire into the coronary artery, while angiography-derived vFFR computes physiology from imaging data already captured during the procedure.

Pie Medical Imaging frames this as a less invasive pathway with a faster workflow, shorter procedure time and shorter fluoroscopy time. Those attributes matter in catheterization laboratories where procedure throughput, radiation dose to patients and staff, and device handling all factor into daily decision-making.

Independent Confirmation of FAST III

The company positions LIPSIA-STRATEGY as independent randomized evidence that reinforces the earlier FAST III findings. Bas Kuppens, CEO of Pie Medical Imaging, said the trial "reinforces the findings of FAST III, adding to the clinical evidence for CAAS vFFR and further strengthening confidence in our angiography-based physiology solution."

Kuppens added that the combination of a less invasive workflow, shorter procedure time and shorter fluoroscopy time brings the company "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."

The PCI Pathway Ambition

The reference to the full PCI pathway is notable. Pie Medical Imaging is not limiting its positioning to a single diagnostic moment. Instead, it is arguing that angiography-based physiology can support decision-making from initial assessment through treatment planning and post-procedural evaluation. If adopted broadly, that framing would place vFFR software closer to the center of the revascularization workflow rather than as an adjunct to wire-based measurement.

Partner and Ecosystem Dynamics

The trial ecosystem behind LIPSIA-STRATEGY spans academic cardiology leadership, multiple participating study centers, and a peer-reviewed publication venue in JACC. That combination carries weight in interventional cardiology, where guideline adoption typically follows randomized evidence published in high-impact journals and presented at major congresses such as TCT.

For Pie Medical Imaging, the strategic value extends beyond a single product claim. The company describes itself as a global leader in cardiovascular image analysis, quantification and visualization, based in Maastricht, The Netherlands, overseeing worldwide innovation and commercialization of the CAAS and 3mensio product lines. Pie Medical Imaging is part of the Esaote Group, a leader in the biomedical equipment sector.

Competitive and Regulatory Context

The announcement emphasizes that the company complies with international quality and regulatory standards, a relevant point for software used in image-guided interventions. The competitive landscape for angiography-based physiology has been active, and a second randomized trial supporting comparable outcomes strengthens the category's evidentiary base. Still, the announcement does not disclose detailed event rates, confidence intervals, or the specific non-inferiority margin, so the strength of the result will be best assessed through the full JACC publication.

Key Takeaways

• LIPSIA-STRATEGY randomized 1,053 patients with intermediate coronary artery stenoses to vFFR-guided or FFR-guided revascularization.
• The primary endpoint was 1-year MACE, and the trial met it by demonstrating non-inferiority for CAAS vFFR guidance.
• Results were presented at TCT 2026 and published simultaneously in JACC.
• The trial was led by Prof. Dr. med. Holger Thiele at the Heart Center Leipzig at Leipzig University.
• Pie Medical Imaging says the findings independently confirm FAST III and support a faster, less invasive workflow with lower radiation exposure.

What to Watch

The immediate question is how interventional cardiology societies and hospital systems will interpret a second randomized result favoring angiography-derived physiology. Adoption decisions will likely hinge on the full published data, local reimbursement and software integration considerations, and whether operators view wire-free physiology as a genuine workflow upgrade rather than a convenience trade-off. For Pie Medical Imaging, the trial provides a stronger evidence platform to argue that physiology-guided decision-making can be broadened across the PCI pathway without the barriers associated with pressure wires.