Boston Scientific has initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the Agent drug-coated balloon (DCB) compared to drug-eluting stents (DES) and/or balloon angioplasty in patients with de novo coronary lesions.
STANCE is a prospective, multicentre, open-label, 1:1 randomised controlled global study of more than 1,600 patients, with a primary endpoint of target lesion failure (TLF) at 12 months. In addition to evaluating de novo small vessel treatment with the Agent DCB, the trial will examine 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 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 USA and help interventional cardiologists determine the optimal treatment strategy for patients living with coronary artery disease.”
The AGENT DCB is the only drug-coated coronary balloon approved for use in the USA and where it is currently indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
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.
