Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon.
The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in diameter.
It will evaluate the 12-month target lesion failure rate, defined as myocardial infarction related to the target vessel, the need for a revascularization procedure or cardiac mortality. The company said at least 480 patients will be enrolled in the study at 40 U.S. sites.
Coronary stenting, which involves inserting a stent into a coronary artery to restore blood flow to the heart, has shown improvement in symptoms and quality of life for patients with coronary artery disease, according to Boston Scientific. However, the stented section of the artery could become obstructed or narrowed by scar tissue and lead to in-stent restenosis (ISR). About 10% of percutaneous coronary interventions address ISR.
“While the possibility of ISR remains a challenge for cardiologists, the Agent DCB provides a potential new approach to re-opening the vessel and reducing the risk of ISR reoccurrence over time,” Robert Yeh, associate professor of medicine at Harvard Medical School and principal investigator on the study, said in a news release. “In this new study, we are evaluating a metal-free and radiation-free treatment that could become a safe and more effective long-term alternative for certain patients.”
Boston Scientific’s Agent DCB is a percutaneous transluminal coronary angioplasty balloon coated with an anti-restenotic drug and delivered through coating technology. It opens narrowed vessels and transfers the drug to the vessel wall.
Agent was granted breakthrough device designation earlier this year.