Real-World Study of Ultimaster Tansei and Nagomi Stents for Coronary Artery Disease Evaluating Safety and Effectiveness in Routine Practice

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the Ultimaster Tansei stent andor Ultimaster Nagomi stent in patients with coronary artery disease during routine clinical practice. This prospective observational study aims to collect real-world data on these stents to better understand their performance and safety profile in everyday medical settings. Participants receive the Ultimaster Tansei stent andor Ultimaster Nagomi stent as part of their usual care for coronary artery stenosis. There are no experimental treatments or placebo groups in this study, as it observes patients who have already received these devices. The study follows patients over time to monitor outcomes related to the stent use. During the study, participants will have clinical follow-ups according to routine care schedules. Researchers will collect data on key outcomes such as the composite event rate of death, nonfatal heart attacks, or ischemic-driven target-vessel revascularization within one year. Secondary outcomes include rates of death, cardiac events, revascularization procedures, stent thrombosis, stroke, procedural success, and bleeding complications monitored up to five years. This long-term observation helps to assess the real-world safety and effectiveness of these stents.

Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent and/or Ultimaster Nagomi™ Stent in Routine Clinical Practice