Enrollment Concluded for EVOLVE II Trial of Boston Scientific's Synergy Stent System

September 12, 2013—Boston Scientific Corporation (Natick, MA) announced it has completed enrollment in the EVOLVE II randomized, controlled clinical trial of the Synergy everolimus-eluting stent system, which features an ultra-thin directional polymer coating that is absorbed by the body shortly after drug elution ends at 3 months.

According to Boston Scientific, the EVOLVE II trial is designed to further assess the safety and effectiveness of the Synergy stent to support US Food and Drug Administration and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.

The EVOLVE II trial began in November 2012 and has enrolled 1,684 patients at 125 sites worldwide, including the United States, Canada, Europe, Australia, New Zealand, Japan, and Singapore. Patients enrolled in the EVOLVE II trial will be followed for 5 years.

Dean Kereiakes, MD, of The Christ Hospital Heart and Vascular Center in Cincinnati, Ohio, is principal investigator for the study. In the company’s press release, Dr. Kereiakes commented, “The Synergy stent is the most flexible, conformable, and deliverable drug-eluting stent I have ever deployed. I am very pleased that the EVOLVE II trial enrolled so quickly and look forward to the study results for this innovative stent, which was designed for optimal vessel healing.”

Boston Scientific noted that the EVOLVE II clinical trial builds upon the EVOLVE study, which was a prospective, randomized, single-blind, first-in-human use study comparing the Synergy stent system to the company’s Promus Element stent system, which uses a durable polymer coating.

In EVOLVE, the Synergy stent showed low rates of target lesion revascularization (1.1%) and no stent thrombosis with the Synergy stent throughout 2 years. Professor Ian Meredith, MD, presented the 2-year EVOLVE outcomes in May at the EuroPCR 2013 scientific program in Paris, France.

Boston Scientific advised that the Synergy stent system is an investigational device in non-CE Mark countries and is not available for sale in the United States and Japan. The company received European CE Mark approval for the Synergy stent system in October 2012.