Biosensors International Group announced on Feb. 15 that the first patient had enrolled in a pivotal clinical trial evaluating the company’s BioFreedom polymer-free drug-coated stent.
The BioFreedom stent is not yet FDA-approved, but it has been implanted in more than 150,000 patients in more than 40 countries outside of the U.S.
Biosensors said the LEADERS FREE II trial is enrolling patients at high bleeding risk who receive antiplatelet therapy for a month. Keith Oldroyd, MD, performed the study’s first implant this week at the Golden Jubilee National Hospital in Glasgow, Scotland.
The researchers plan on enrolling patients at sites in the U.S., Canada, Denmark, France, Germany, Italy and the United Kingdom. The FDA granted the trial an investigational device exemption designation.
Biosensors expects to complete the LEADERS FREE II trial by July 2021. The primary outcomes are the composite of cardiac death and MI at six months and the incidence of clinically driven target lesion revascularization at six months.
The original LEADERS FREE trial found that the BioFreedom was significantly safer and more effective at two years compared with a bare metal stent. The results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in October and simultaneously published in the Journal of the American College of Cardiology.
At two years, 6.8 percent of patients in the BioFreedom group and 12 percent of patients in the bare metal stent group had clinically driven target-lesion revascularization, which was the study’s primary endpoint. Meanwhile, major bleeding occurred in 8.9 percent and 9.2 percent of patients, respectively, while a coronary thrombotic event occurred in 8.2 percent and 10.6 percent of patients, respectively.
The one-year LEADERS FREE results were presented at the TCT conference in October 2015.