Aug. 21, 2025 — Boston Scientific has initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the AGENT Drug-Coated Balloon (DCB) compared to the standard of care – percutaneous coronary intervention (PCI) treatment with drug-eluting stents (DES) and/or balloon angioplasty – in patients with de novo (previously untreated) coronary lesions.
- STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled global study of more than 1,600 patients.
- The primary endpoint is defined as target lesion failure (TLF) at 12 months.
- In addition to evaluating de novo small vessel treatment with the AGENT DCB, this trial is notable for specifically examining the use of the device in patients with bifurcations and long lesions.
“This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Dr. Janar Sathananthan, chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “Positive results from this trial will support an expanded indication of the AGENT DCB in the U.S. and help interventional cardiologists determine the optimal treatment strategy for patients living with coronary artery disease.”
About AGENT DCB
- The AGENT DCB is the only drug-coated coronary balloon approved for use in the U.S. and is currently indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
- Traditional therapies used to treat ISR in the U.S. have included placing additional layers of metal stents, uncoated balloon angioplasty and radiation, all of which may not provide ideal outcomes in some cases.
- Clinical data from the pivotal AGENT IDE clinical trial demonstrated that the AGENT DCB was statistically superior to conventional (uncoated) balloon angioplasty for the primary endpoint of target lesion failure at 12 months.
November 14, 2025 
