Lahr Schwarzwald

Researchers are evaluating the use of a new device called the pressure microcatheter compared to the traditional pressure wire in guiding treatment decisions and optimizing percutaneous coronary intervention (PCI) for patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome. This Phase 4, multicenter, randomized, open-label trial aims to see if clinical outcomes with the pressure microcatheter are not worse than those with the pressure wire. The pressure microcatheter is designed to provide similar physiological measurements while being easier to use during the procedure. Participants will be randomly assigned to one of four groups: pressure microcatheter guided strategy with incremental optimization (PIOS MC), pressure wire guided strategy with incremental optimization (PIOS PW), pressure microcatheter guided strategy with standard care, or pressure wire guided strategy with standard care. Each group will receive PCI guided by their assigned device, followed by either the incremental optimization strategy or standard care treatment as described. The study device is used during the PCI procedure to measure lesion severity and help guide treatment. During the study, patients will be monitored in the hospital and followed up at 12 months, then yearly for up to five years. Researchers will compare major adverse cardiac events (MACE) occurring within 12 months between the two device strategies. Assessments will include clinical evaluations and tracking of outcomes related to heart health and procedure success. This long-term follow-up will help determine the safety and effectiveness of using the pressure microcatheter compared to the pressure wire in guiding PCI.