Medtronic Begins Bifurcation Cohort of the RESOLUTE ONYX Postapproval Study

May 18, 2018—Medtronic announced the initiation of a clinical study in the United States to assess the safety and efficacy of drug-eluting stents (DESs) for the treatment of bifurcation lesions. The Bifurcation Cohort, part of the RESOLUTE ONYX Postapproval Study, will include patients with coronary artery disease undergoing implantation of Medtronic's Resolute Onyx DES in sizes ranging from 2 to 5 mm in diameter.

The multicenter, single-arm study intends to enroll 250 patients with bifurcation lesions at 30 sites in the United States and Europe. The primary endpoint is target vessel failure at 12 months. Study participants will be followed for 3 years and undergo 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 DES from the US Food and Drug Administration (FDA).

Matthew J. Price, MD, interventional cardiologist at Scripps Clinic in La Jolla, California, is the National Principal Investigator of the Bifurcation Cohort of the RESOLUTE ONYX Postapproval Study. In Medtronic's announcement, Dr. Price commented, "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 the company, the Resolute Onyx DES received European CE Mark approval in September 2014. In the United States, the device received FDA approval in April 2017.

The Resolute Onyx DES is currently indicated in the United States for improving coronary luminal diameters in patients, including those with diabetes mellitus and symptomatic ischemic heart disease caused by de novo lesions ≤ 35 mm long in native coronary arteries with reference vessel diameters of 2 to 5 mm. The Resolute Onyx DES is not approved for the treatment of bifurcation lesions in the United States, advised Medtronic.