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

Clinical Inclusion Criteria: * Subject must be at least 18 years of age. * Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. * Subject is eligible for percutaneous coronary intervention (PCI). * Subject is willing to comply with all protocol-required follow-up evaluation. * Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure. Angiographic Inclusion Criteria: * Target lesion is a de novo lesion located in a native coronary artery * Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic subjects (\>70% and \<100% in asymptomatic subjects) prior to lesion pre-dilation. * Target lesion must be successfully pre-dilated. * If a non-target lesion is treated, it must be treated first and must be deemed a success. Clinical Exclusion Criteria: * Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months. * Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.). * Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation. * Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint. * S…