Comparing Pressure Microcatheter and Pressure Wire to Guide and Optimize PCI in Coronary Artery Disease and Acute Coronary Syndrome Patients

What this Trial Is About

Researchers are evaluating the use of a new device called the pressure microcatheter to measure the severity of coronary artery lesions in patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome ACS. This trial compares clinical outcomes of patients guided by the pressure microcatheter versus those guided by the conventional pressure wire during percutaneous coronary intervention PCI. The study aims to determine if the pressure microcatheter strategy is not worse than the pressure wire strategy for clinical decision making. Participants will be randomly assigned to receive PCI guided by either the pressure microcatheter or the pressure wire. After an angiographically successful PCI, patients will either undergo fractional flow reserve FFR-guided stent optimization using the assigned device or receive standard care treatment. The interventions are compared in four groups pressure microcatheter with optimization, pressure wire with optimization, pressure microcatheter with standard care, and pressure wire with standard care. Participants will be followed in hospital initially, then at 12 months, and yearly up to five years to monitor clinical outcomes. The study involves collecting data on major adverse cardiac events MACE, procedural times, resource use during hospitalization, post-PCI FFR measurements, and rates of symptoms and complications. This follow-up aims to assess safety, effectiveness, and long-term results of the two guidance strategies.

INSIGHTFUL-FFR Clinical Trial