Medtronic has started the US clinical study for the evaluation of safety and efficacy of drug-eluting stents (DES) to treat bifurcation lesions in patients with coronary artery disease (CAD).
The bifurcation cohort, which is part of Resolute Onyx post-approval study, will recruit patients with CAD receiving the Resolute Onyx DES in sizes ranging between 2.0mm and 5.0mm in diameter.
Resolute Onyx DES has not yet secured approval for the treatment of bifurcation lesions in the US.
Bifurcation cohort national principal investigator Dr Matthew Price said: “Patients with bifurcation lesions present a unique challenge for interventional cardiologists. This study will help us evaluate these patients in a controlled setting, which will help expand our knowledge base.”
Resolute Onyx DES platform is claimed to be the first and only DES to feature core wire technology (CST), which is a Medtronic method of stent manufacturing that involves making a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent.
The company will recruit up to 250 patients with bifurcation lesions in the multi-center and single-arm study at 30 sites in the US and Europe.
According to the company, the primary endpoint is target vessel failure (TVF) at 12 months and date from the study will be used to submit application with the FDA for an expanded indication to include bifurcation lesions for the Resolute Onyx DES.
Medtronic cardiac and vascular group’s coronary and renal denervation business general manager and vice president Dave Moeller said: “As a leader in next-generation coronary stent technology, we continue to invest in generating robust clinical evidence to address unmet needs in interventional cardiology.
“We look forward to working with participating centers to begin enrolling patients in this important study.”
Resolute Onyx DES secured CE mark approval in September 2014, while FDA approval in April 2017. It is currently used in the US to improve coronary luminal diameters in patients, including those with diabetes mellitus.