Boston Scientific has initiated patient recruitment in a randomised, single-blind, non-inferiority, trial named 'Evolve clinical trial' evaluating safety and performance of Synergy Coronary Stent.
Boston Scientific expects to recruit 291 patients at up to 35 sites in Europe, Australia and New Zealand. The data from the trial will be used to support CE Mark approval for the Synergy Stent.
Boston Scientific said that its Synergy Stent works by using a bioabsorbable PLGA polymer and everolimus drug formulation so as to create a thin, uniform coating confined to the outer surface of the stent.
Boston Scientific claimed that the Synergy Stent features the same proprietary platinum chromium alloy and stent design used in the Promus Element Stent to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility.
Reportedly, the Evolve clinical trial is expected to compare the Synergy Stent to the Promus Element Everolimus-Eluting Coronary Stent in patients with a single de novo native coronary artery lesion.
In the trial, the two drug doses will be evaluated with the Synergy Stent, including an everolimus dose approximately equal to that of the Promus Element Stent and a dose equivalent to half that amount.
Keith Dawkins, senior vice president and chief medical officer of cardiology, rhythm and vascular group at Boston Scientific, said: “The Synergy Stent is designed to significantly reduce the amount of polymer and drug to which the vessel wall is exposed, while eliminating the coating on the inner surface of the stent where endothelial cell growth is required for healing.”
Hank Kucheman, executive vice president and president of cardiology, rhythm and vascular group at Boston Scientific, said: “The Synergy Stent is designed to combine the acute performance advantages of the platinum chromium Promus Element Stent with an bioabsorbable polymer.”