Study Comparing AGENT Drug-Coated Balloon to Standard PCI Treatment with Drug Eluting Stents for New Coronary Artery Lesions

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the AGENT Drug-Coated Balloon AGENT DCB compared to the standard care involving drug eluting stent DES andor balloon angioplasty in patients with new de novo coronary artery lesions. The study is prospective, multicenter, open-label, and randomized. It includes a pharmacokinetic PK sub-study and an intravascular ultrasound IVUS sub-study to gather additional data. Participants are assigned to one of several groups based on lesion types such as small vessels, bifurcation side branches, and long lesions. They receive either the AGENT DCB or standard care treatments including drug eluting stents or plain old balloon angioplasty POBA. The study compares these treatments in parallel groups according to the specific lesion characteristics. During the study, participants undergo the assigned procedure followed by protocol-required evaluations and follow-up visits to monitor outcomes. Researchers will assess the primary outcome of target lesion failure rate at 12 months. Participants are monitored for safety and effectiveness, with ongoing assessments throughout the study duration which continues until March 2032.

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