Boston Scientific has completed patient enrollment in the Evolve clinical trial, designed to assess the safety and performance of the company's fourth-generation Synergy Coronary Stent.
The randomized, single-blind, non-inferiority trial will compare the Synergy Stent to the Promus Element Everolimus-Eluting Coronary Stent in patients with a single de novo native coronary artery lesion.
The Evolve trial compares two doses of everolimus on the Synergy Stent (a Promus Element equivalent dose and a dose half that amount) randomized against a commercially available Promus Element Stent.
The primary clinical endpoint is target lesion failure at 30 days, a composite measure of cardiac death, myocardial infarction and target lesion revascularization.
The primary angiographic endpoint is in-stent late loss at six months as measured by quantitative coronary angiography (QCA).
In the study, patients will also be assessed by intravascular ultrasound (IVUS) at the time of initial procedure and at six months.
Boston Scientific Cardiology Rhythm and Vascular Group executive vice president and president Hank Kucheman said completion of enrollment brings their fourth-generation drug-eluting stent platform another step closer to commercialization.
"The Synergy Stent demonstrates our commitment to innovation and clinical science in pursuit of the most advanced treatment options for our physicians and their patients and we are confident that the Synergy Stent will enhance our leading drug-eluting stent portfolio," Kucheman said.