Medtronic has announced the initiation of a clinical study in the US to assess the safety and efficacy of drug-eluting stents for the treatment of bifurcation lesions. The Bifurcation Cohort, part of the RESOLUTE ONYX Post-Approval Study, will include patients with coronary artery disease receiving the Resolute Onyx drug-eluting stent in sizes ranging from 2mm to 5mm in diameter. The Resolute Onyx DES is not approved for the treatment of bifurcation lesions in the USA.
The multicentre, single-arm study intends to enrol 250 patients with bifurcation lesions from 30 sites in the USA and Europe. The primary endpoint is target vessel failure at 12 months. Study participants will be followed for three years and receive regular follow-up health assessments. Data from the study will be used to support an application for an indication expansion to include bifurcation lesions for the Resolute Onyx drug-eluting stents from the US FDA.
Matthew J Price (Scripps Clinic, La Jolla, USA), national principal investigator of the Bifurcation Cohort of the RESOLUTE ONYX post-approval study, says: “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. The unique design of Resolute Onyx DES may be well-suited to treat bifurcation lesions in a wide range of vessel sizes.”
According to a press release, the Resolute Onyx drug-eluting stent platform is the first-and-only drug-eluting stent to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology. The press release notes that a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. Core Wire Technology enables thinner struts while maintaining structural strength and visibility.
Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, comments: “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 centres to begin enrolling patients in this important study.”