Boston Scientific Launches STANCE Trial for Agent DCB in De Novo Coronary Lesions

August 22, 2025—Boston Scientific Corporation has launched the STANCE trial evaluating the Agent drug-coated balloon (DCB) in patients with de novo coronary lesions. STANCE is a global, prospective, multicenter, open-label, 1:1 randomized controlled trial that will compare the Agent DCB to standard percutaneous coronary intervention treatments, including drug-eluting stents and balloon angioplasty, across more than 1,600 patients worldwide.

The trial’s primary endpoint is target lesion failure at 12 months, with a special focus on small vessels, bifurcations, and long lesions.

“This important study will evaluate the potential benefits of the Agent DCB for patients with certain anatomic 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 United States and help interventional cardiologists determine the optimal treatment strategy for patients living with coronary artery disease.”

According to Boston Scientific, the Agent DCB is the only FDA-approved drug-coated coronary balloon in the United States and is currently indicated for treating in-stent restenosis. It previously showed superior outcomes to uncoated balloon angioplasty in the AGENT IDE trial.