AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.
• 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.
• 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.