AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions

[...] sion is a de novo lesion located in a native coronary artery. Target lesion must have visually estimated stenosis > 50% a [...] s with substance abuse (e.g. alcohol, cocaine, heroin, etc.) as assessed by Investigator. Subject has planned procedure that may cause non-complianc [...] ect has left ventricular ejection fraction known to be < 30% within the last 12 months. Subject had PCI or other coronary interventions within the last 303 days. Subject has planned PCI or CABG after the index proce [...] MI <72h prior to the index procedure. Subject presents with NSTEMIACS and rising biomarkers, or ongoing chest pain o [...] [...]