Biosensors International Group has enrolled the first patient in a clinical trial of its polymer-free drug-coated stent (DCS), designed for use in patients with high risk of bleeding.
Featuring a micro-structured abluminal surface, the BioFreedom DCS permits the controlled release of a highly lipophilic anti-restenotic drug, Biolimus A9 (BA9), without the use of a polymer.
The double-blind, prospective, randomised trial, named LEADERS FREE, has enrolled the first patient at the Hopital de la Tour in Geneva, Switzerland.
The trial will compare the safety of the BioFreedom with a bare-metal stent (BMS), as well as the ability to deliver the anti-restenotic benefit of a drug-eluting stent (DES), with only a one-month course of DAPT.
Non-inferiority of BioFreedom compared with BMS as measured by specific safety factors (cardiac death, myocardial infarction, and definite/probable stent thrombosis) as well as superiority over BMS in terms of clinically-driven TLR at one year are the co-primary endpoints of the study.
The study will also include 2,500 patients with high risk of bleeding from 60 sites across Europe, Asia and South America, and will be followed-up for two years.
The company, which should complete the enrolment process by early 2014, is expected to present the trial’s primary endpoint data during 2015.
In addition, the BioFreedom FIM study’s three-year results showed similar rates of MACE, cardiac artery bypass graft and target lesion revascularistion between BioFreedom and Boston Scientific’s Taxus Liberté DES, with no evidence of stent thrombosis in either group.
Biosensors cardiovascular business unit president Jeffrey Jump said; "We anticipate that the results from LEADERS FREE will bring real benefits to patients at high risk of bleeding, who cannot currently be given a drug-eluting stent due to the need for a prolonged course of DAPT."