AI-Driven Angiography-Based Fractional Flow Reserve Compared to Invasive FFR to Guide PCI in Coronary Artery Disease

What this Trial Is About

Researchers are evaluating the use of an artificial intelligence-driven angiography-based fractional flow reserve MPFFR compared with invasive fractional flow reserve FFR to guide percutaneous coronary intervention PCI in patients with coronary artery disease. This multi-center, randomized controlled trial aims to determine if MPFFR-guided PCI is not inferior to invasive FFR-guided PCI in terms of clinical outcomes. The study addresses limitations of current FFR methods, such as the need for pressure wires and drug-induced hyperemia, by testing a faster, automated AI-based alternative. Participants will be randomly assigned to one of two groups the MPFFR-guided PCI group or the invasive FFR-guided PCI group. In the MPFFR group, AI software analyzes angiographic images to measure blood flow reserve without manual segmentation, with PCI recommended for lesions showing MPFFR values of 0.80 or less. In the invasive FFR group, a pressure wire and drugs are used to measure FFR, with PCI recommended for lesions with FFR values of 0.80 or less. Decisions to perform PCI are made by the treating doctors, and reasons for deferral are recorded. During the study, participants will undergo diagnostic coronary angiography followed by the assigned FFR measurement method. Researchers will monitor major adverse cardiac events one year after the last patient enrolls, along with other outcomes such as death, heart attacks, revascularization procedures, and procedure-related measures. The trial includes detailed follow-up to assess safety and effectiveness, with data collected on procedure times, contrast use, and device performance throughout the study period.

Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)