Medical device company Biosensors International Group has enrolled the first patient in a clinical trial evaluating the company’s BioFreedom polymer-free-drug coated stent.
The ‘Leaders Free II trial’ is enrolling patients at high bleeding risk who receive anti-platelet treatment for a month. The study’s first implant was performed this week at the Golden Jubilee National Hospital in Glasgow Scotland.
Researchers plan on enrolling patients at sites in the US, Canada, Denmark, France, Germany, Italy and the UK.
The BioFreedom stent in not yet FDA-approved, but the organisation granted the trial an investigational device exemption designation.
Biosensors expects to complete the ‘Leaders Free II trial’ by July 2021. The primary outcomes for the trial are the composite of cardiac death and MI at six month and the incidence of clinically driven target lesion revascularisation at six months.
An earlier trial found that BioFreedom was significantly safer and more effective at two years compared with a bare metal stent. The results showed that at two years, almost 7% of patients in the BioFreedom group and 12% of patients in the bare metal stent group had clinically driven target-lesion revascularisation. Meanwhile, a major bleeding occurred in 8.9% and 9.2% of patient respectively, while a coronary thrombotic event occurred in 8.2% and 10.6% of patients.
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.