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

NARecruitingINTERVENTIONAL

Enrollment

1,616

Participants

Timeline

Start Date

August 21, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2032

Conditions

Coronary Arterial Disease (CAD)de Novo Lesions in Native Coronary Arteries

Interventions

DEVICE

Drug Eluting Balloon

AGENT DCB

DEVICE

Drug eluting stent

Any commercially available DES used for standard of care.

PROCEDURE

Plain old balloon angioplasty

Bifurcation side branch - POBA

Trial Locations (1)

RECRUITING

UPMC Pinnacle, Mechanicsburg