Study of Double-Effect Kissing Balloon Technique Using Drug Eluting and Perfusion Balloons for Left Main Coronary Artery Disease JDEPTH-LM Registry

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Double-effect kissing balloon technique W-KBT using Perfusion balloon PB and Drug coated balloon DCB in patients with left main coronary artery disease LMD who have left circumflex artery LCx ostium stenosis. This prospective, observational, multi-center study focuses on patients with stable angina, non-ST-elevation myocardial infarction, or unstable angina who require percutaneous coronary intervention PCI. Patients who meet the selection criteria will receive PCI with W-KBT following crossover stenting for LMT-LAD direction, proximal optimization technique POT, and conventional kissing balloon technique C-KBT as part of usual care. Approximately 280 participants aged 18 and older will be enrolled across 17 sites in Japan. The study will monitor patients through hospital discharge and for 12 months afterward during routine clinical practice. Participants will be followed to assess procedure success during PCI and major adverse cardiovascular events MACE within 12 months. Additional measures include time to ST-change from DCB inflation, total DCB inflation time, changes in blood pressure and heart rate, use of vasopressors or mechanical support after W-KBT, and incidence of ischemia-driven revascularization at the LCx ostium. Data will be collected to evaluate the efficacy and safety of this treatment approach over the year following the procedure.

Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)