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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.
According to the company, STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled global study of more than 1,600 patients for evaluation of de novo small vessel treatment with the AGENT DCB. The primary endpoint is defined as target lesion failure (TLF) at 12 months. Additionally, 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.”
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